Trial Outcomes & Findings for Kansas University DHA Outcome Study (KUDOS) Follow-Up (NCT NCT02487771)
NCT ID: NCT02487771
Last Updated: 2018-02-07
Results Overview
The Full Scale IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's general intellectual ability based upon assessments of verbal, cognitive, and performance domains. At three years the Full Scale IQ score has a range of 41 (poorest performance) to 155 (best performance). For the older ages the score can range from 40 to 160. For all ages the assessment is normed to a Mean = 100, St Dev = 15.
COMPLETED
PHASE3
190 participants
36 Months
2018-02-07
Participant Flow
Participants were recruited from 7/17/2008 to 4/24/2012.
Participants were required to have been enrolled in the parent trial.
Participant milestones
| Measure |
Placebo Capsule
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Overall Study
STARTED
|
91
|
99
|
|
Overall Study
COMPLETED
|
81
|
85
|
|
Overall Study
NOT COMPLETED
|
10
|
14
|
Reasons for withdrawal
| Measure |
Placebo Capsule
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Moved out of area
|
5
|
6
|
|
Overall Study
Withdrawal by Subject
|
3
|
5
|
Baseline Characteristics
Kansas University DHA Outcome Study (KUDOS) Follow-Up
Baseline characteristics by cohort
| Measure |
Placebo Capsule
n=91 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=99 Participants
DHA: 600 mg DHA capsule
|
Total
n=190 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
2.01 years
STANDARD_DEVIATION 0.03 • n=5 Participants
|
2.01 years
STANDARD_DEVIATION 0.03 • n=7 Participants
|
2.01 years
STANDARD_DEVIATION 0.03 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic
|
81 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Black
|
58 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
91 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
190 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 36 MonthsPopulation: Missing data for participants dues to attrition, missed appointments, refusals, or questionable test.
The Full Scale IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's general intellectual ability based upon assessments of verbal, cognitive, and performance domains. At three years the Full Scale IQ score has a range of 41 (poorest performance) to 155 (best performance). For the older ages the score can range from 40 to 160. For all ages the assessment is normed to a Mean = 100, St Dev = 15.
Outcome measures
| Measure |
Placebo Capsule
n=74 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=88 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ
|
98.78 units on a scale
Standard Deviation 15.43
|
98.75 units on a scale
Standard Deviation 15.75
|
PRIMARY outcome
Timeframe: 48 MonthsPopulation: Missing data for participants dues to attrition, missed appointments, refusals, or questionable test.
The Full Scale IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's general intellectual ability based upon assessments of verbal, cognitive, and performance domains. At three years the Full Scale IQ score has a range of 41 (poorest performance) to 155 (best performance). For the older ages the score can range from 40 to 160. For all ages the assessment is normed to a Mean = 100, St Dev = 15.
Outcome measures
| Measure |
Placebo Capsule
n=66 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=79 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ
|
97.52 units on a scale
Standard Deviation 15.32
|
99.72 units on a scale
Standard Deviation 16.10
|
PRIMARY outcome
Timeframe: 72 MonthsPopulation: Missing data for participants dues to attrition, missed appointments, refusals, or questionable test.
The Full Scale IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's general intellectual ability based upon assessments of verbal, cognitive, and performance domains. At three years the Full Scale IQ score has a range of 41 (poorest performance) to 155 (best performance). For the older ages the score can range from 40 to 160. For all ages the assessment is normed to a Mean = 100, St Dev = 15.
Outcome measures
| Measure |
Placebo Capsule
n=69 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=81 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ
|
100.67 units on a scale
Standard Deviation 14.70
|
102.21 units on a scale
Standard Deviation 14.02
|
PRIMARY outcome
Timeframe: 60 MonthsPopulation: Missing data due to attrition, missed appointments, refusals, or questionable test.
The Peabody Picture Vocabulary Test, 3rd Edition provides a standardized assessment of a person's receptive vocabulary. The Standard Score can range from 40 (poorest performance) to 160 (best performance) and has been normed to a Mean = 100, St Dev = 15.
Outcome measures
| Measure |
Placebo Capsule
n=74 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=85 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Cognitive Function Score - Peabody Picture Vocabulary Test
|
101.07 units on a scale
Standard Deviation 14.92
|
102.35 units on a scale
Standard Deviation 15.33
|
PRIMARY outcome
Timeframe: 42 MonthsPopulation: Missing data due to attrition, missed appointments, refusals, or questionable test.
The Test of Preschool Early Literacy provides a standardized Early Literacy Index score, a measure of general, early literacy skills that relate to later reading and writing skill acquisition. The score is based on assessments of vocabulary, print knowledge, and phonological awareness. The score can range from 40 (poorest performance) to 144 (best performance) and has been normed to a Mean = 100, St Dev = 15.
Outcome measures
| Measure |
Placebo Capsule
n=71 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=87 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Cognitive Function Score - Test of Preschool Early Literacy
|
92.99 units on a scale
Standard Deviation 18.76
|
95.08 units on a scale
Standard Deviation 18.80
|
PRIMARY outcome
Timeframe: 36 MonthsPopulation: Missing data due to attrition, missed appointments, refusals, or questionable test
The Verbal IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's verbal ability based upon assessments of vocabulary, general knowledge, and reasoning. At three years the Verbal IQ score has a range of 49 (poorest performance) to 150 (best performance). For the older ages the score can range from 46 to 155. For all ages the assessment is normed to a Mean = 100, St Dev = 15.
Outcome measures
| Measure |
Placebo Capsule
n=77 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=91 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ
|
100.98 units on a scale
Standard Deviation 14.22
|
101.10 units on a scale
Standard Deviation 16.51
|
PRIMARY outcome
Timeframe: 48 MonthsPopulation: Missing data due to attrition, missed appointments, refusals, or questionable test
The Verbal IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's verbal ability based upon assessments of vocabulary, general knowledge, and reasoning. At three years the Verbal IQ score has a range of 49 (poorest performance) to 150 (best performance). For the older ages the score can range from 46 to 155. For all ages the assessment is normed to a Mean = 100, St Dev = 15.
Outcome measures
| Measure |
Placebo Capsule
n=67 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=80 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ
|
99.30 units on a scale
Standard Deviation 15.31
|
100.13 units on a scale
Standard Deviation 16.13
|
PRIMARY outcome
Timeframe: 72 MonthsPopulation: Missing data due to attrition, missed appointments, refusals, or questionable test
The Verbal IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's verbal ability based upon assessments of vocabulary, general knowledge, and reasoning. At three years the Verbal IQ score has a range of 49 (poorest performance) to 150 (best performance). For the older ages the score can range from 46 to 155. For all ages the assessment is normed to a Mean = 100, St Dev = 15.
Outcome measures
| Measure |
Placebo Capsule
n=70 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=81 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ
|
101.53 units on a scale
Standard Deviation 14.20
|
102.44 units on a scale
Standard Deviation 14.88
|
SECONDARY outcome
Timeframe: 36 MonthsPopulation: Missing data due to attrition, missed appointments, refusals.
The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child's behaviors as reported by a parent. Externalizing Problems is a measure of Aggression and Hyperactivity. Internalizing Problems is a measure of Anxiety, Depression, and Somatization. The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems. Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership. All scores are derived from the general, combined sex normative tables of T-Scores. For Adaptive Skills higher T-Scores reflect a more optimal outcome. For all other measures lower T-Scores reflect a more optimal outcome. All T-Scores were standardized with a Mean = 50, St Dev = 10.
Outcome measures
| Measure |
Placebo Capsule
n=71 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=82 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Adaptive Regulation Assessment
Externalizing Problems
|
48.17 T-scores
Standard Deviation 6.86
|
49.11 T-scores
Standard Deviation 7.85
|
|
Adaptive Regulation Assessment
Internalizing Problems
|
49.31 T-scores
Standard Deviation 9.67
|
49.10 T-scores
Standard Deviation 8.05
|
|
Adaptive Regulation Assessment
Behavioral Symptoms
|
47.99 T-scores
Standard Deviation 7.13
|
49.46 T-scores
Standard Deviation 6.85
|
|
Adaptive Regulation Assessment
Adaptive Skills
|
54.00 T-scores
Standard Deviation 7.49
|
52.56 T-scores
Standard Deviation 7.23
|
SECONDARY outcome
Timeframe: 48 MonthsPopulation: Missing data due to attrition, missed appointments, refusals.
The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child's behaviors as reported by a parent. Externalizing Problems is a measure of Aggression and Hyperactivity. Internalizing Problems is a measure of Anxiety, Depression, and Somatization. The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems. Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership. All scores are derived from the general, combined sex normative tables of T-Scores. For Adaptive Skills higher T-Scores reflect a more optimal outcome. For all other measures lower T-Scores reflect a more optimal outcome. All T-Scores were standardized with a Mean = 50, St Dev = 10.
Outcome measures
| Measure |
Placebo Capsule
n=74 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=85 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Adaptive Regulation Assessment
Externalizing Problems
|
48.87 T-scores
Standard Deviation 8.22
|
50.08 T-scores
Standard Deviation 8.22
|
|
Adaptive Regulation Assessment
Internalizing Problems
|
47.30 T-scores
Standard Deviation 8.65
|
47.46 T-scores
Standard Deviation 8.73
|
|
Adaptive Regulation Assessment
Behavioral Symptoms
|
49.42 T-scores
Standard Deviation 8.62
|
50.59 T-scores
Standard Deviation 7.20
|
|
Adaptive Regulation Assessment
Adaptive Skills
|
50.15 T-scores
Standard Deviation 8.76
|
47.72 T-scores
Standard Deviation 8.40
|
SECONDARY outcome
Timeframe: 60 MonthsPopulation: Missing data due to attrition, missed appointments, refusals.
The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child's behaviors as reported by a parent. Externalizing Problems is a measure of Aggression and Hyperactivity. Internalizing Problems is a measure of Anxiety, Depression, and Somatization. The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems. Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership. All scores are derived from the general, combined sex normative tables of T-Scores. For Adaptive Skills higher T-Scores reflect a more optimal outcome. For all other measures lower T-Scores reflect a more optimal outcome. All T-Scores were standardized with a Mean = 50, St Dev = 10.
Outcome measures
| Measure |
Placebo Capsule
n=72 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=83 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Adaptive Regulation Assessment
Externalizing Problems
|
48.94 T-scores
Standard Deviation 8.71
|
50.43 T-scores
Standard Deviation 9.22
|
|
Adaptive Regulation Assessment
Internalizing Problems
|
49.99 T-scores
Standard Deviation 7.96
|
49.21 T-scores
Standard Deviation 8.75
|
|
Adaptive Regulation Assessment
Behavioral Symptoms
|
50.17 T-scores
Standard Deviation 7.66
|
50.78 T-scores
Standard Deviation 8.19
|
|
Adaptive Regulation Assessment
Adaptive Skills
|
52.09 T-scores
Standard Deviation 8.18
|
50.96 T-scores
Standard Deviation 8.13
|
SECONDARY outcome
Timeframe: 72 MonthsPopulation: Missing data due to attrition, missed appointments, refusals.
The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child's behaviors as reported by a parent. Externalizing Problems is a measure of Aggression and Hyperactivity. Internalizing Problems is a measure of Anxiety, Depression, and Somatization. The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems. Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership. All scores are derived from the general, combined sex normative tables of T-Scores. For Adaptive Skills higher T-Scores reflect a more optimal outcome. For all other measures lower T-Scores reflect a more optimal outcome. All T-Scores were standardized with a Mean = 50, St Dev = 10.
Outcome measures
| Measure |
Placebo Capsule
n=67 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=75 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Adaptive Regulation Assessment
Externalizing Problems
|
50.10 T-scores
Standard Deviation 9.68
|
49.37 T-scores
Standard Deviation 6.76
|
|
Adaptive Regulation Assessment
Internalizing Problems
|
46.80 T-scores
Standard Deviation 7.80
|
45.96 T-scores
Standard Deviation 8.35
|
|
Adaptive Regulation Assessment
Behavioral Symptoms
|
48.99 T-scores
Standard Deviation 8.09
|
49.17 T-scores
Standard Deviation 6.72
|
|
Adaptive Regulation Assessment
Adaptive Skills
|
51.80 T-scores
Standard Deviation 8.09
|
49.73 T-scores
Standard Deviation 9.77
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
Outcome measures
| Measure |
Placebo Capsule
n=85 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=97 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Anthropometrics: Weight-for-age
|
12.66 Kilogram (kg)
Standard Deviation 1.51
|
12.99 Kilogram (kg)
Standard Deviation 1.44
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2.5 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
Outcome measures
| Measure |
Placebo Capsule
n=86 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=97 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Anthropometrics: Weight-for-age
|
13.70 Kilogram (kg)
Standard Deviation 1.66
|
14.08 Kilogram (kg)
Standard Deviation 1.51
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
Outcome measures
| Measure |
Placebo Capsule
n=87 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=97 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Anthropometrics: Weight-for-age
|
14.83 Kilogram (kg)
Standard Deviation 1.76
|
15.16 Kilogram (kg)
Standard Deviation 1.60
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.
Outcome measures
| Measure |
Placebo Capsule
n=83 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=97 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Anthropometrics: Height-for-Age
|
85.91 Centimeters (cm)
Standard Deviation 3.42
|
86.54 Centimeters (cm)
Standard Deviation 3.09
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3.5 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
Outcome measures
| Measure |
Placebo Capsule
n=85 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=95 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Anthropometrics: Weight-for-age
|
15.90 Kilogram (kg)
Standard Deviation 1.91
|
16.36 Kilogram (kg)
Standard Deviation 1.85
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
Outcome measures
| Measure |
Placebo Capsule
n=87 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=91 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Anthropometrics: Weight-for-age
|
17.13 Kilogram (kg)
Standard Deviation 2.11
|
17.71 Kilogram (kg)
Standard Deviation 2.10
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4.5 yearsBiannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
Outcome measures
| Measure |
Placebo Capsule
n=86 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=91 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Anthropometrics: Weight-for-age
|
18.29 Kilogram (kg)
Standard Deviation 2.38
|
18.96 Kilogram (kg)
Standard Deviation 2.55
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
Outcome measures
| Measure |
Placebo Capsule
n=83 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=88 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Anthropometrics: Weight-for-age
|
19.75 Kilogram (kg)
Standard Deviation 2.85
|
20.33 Kilogram (kg)
Standard Deviation 3.05
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5.5 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
Outcome measures
| Measure |
Placebo Capsule
n=81 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=85 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Anthropometrics: Weight-for-age
|
21.23 Kilogram (kg)
Standard Deviation 3.5
|
21.73 Kilogram (kg)
Standard Deviation 3.18
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
Outcome measures
| Measure |
Placebo Capsule
n=81 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=85 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Anthropometrics: Weight-for-age
|
22.68 Kilogram (kg)
Standard Deviation 4.16
|
23.14 Kilogram (kg)
Standard Deviation 3.66
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2.5 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.
Outcome measures
| Measure |
Placebo Capsule
n=86 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=96 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Anthropometrics: Height-for-Age
|
90.66 Centimeters (cm)
Standard Deviation 3.10
|
91.17 Centimeters (cm)
Standard Deviation 3.69
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.
Outcome measures
| Measure |
Placebo Capsule
n=87 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=96 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Anthropometrics: Height-for-Age
|
94.90 Centimeters (cm)
Standard Deviation 3.48
|
95.29 Centimeters (cm)
Standard Deviation 3.52
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3.5 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.
Outcome measures
| Measure |
Placebo Capsule
n=85 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=95 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Anthropometrics: Height-for-Age
|
98.96 Centimeters (cm)
Standard Deviation 3.79
|
99.27 Centimeters (cm)
Standard Deviation 3.58
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.
Outcome measures
| Measure |
Placebo Capsule
n=87 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=91 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Anthropometrics: Height-for-Age
|
102.77 Centimeters (cm)
Standard Deviation 3.82
|
103.32 Centimeters (cm)
Standard Deviation 3.91
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4.5 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.
Outcome measures
| Measure |
Placebo Capsule
n=86 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=91 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Anthropometrics: Height-for-Age
|
106.39 Centimeters (cm)
Standard Deviation 4.23
|
107.11 Centimeters (cm)
Standard Deviation 4.09
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.
Outcome measures
| Measure |
Placebo Capsule
n=83 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=88 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Anthropometrics: Height-for-Age
|
110.03 Centimeters (cm)
Standard Deviation 4.30
|
110.58 Centimeters (cm)
Standard Deviation 4.23
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5.5 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.
Outcome measures
| Measure |
Placebo Capsule
n=81 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=85 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Anthropometrics: Height-for-Age
|
113.41 Centimeters (cm)
Standard Deviation 4.39
|
114.01 Centimeters (cm)
Standard Deviation 4.34
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.
Outcome measures
| Measure |
Placebo Capsule
n=81 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=85 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Anthropometrics: Height-for-Age
|
116.76 Centimeters (cm)
Standard Deviation 4.74
|
117.22 Centimeters (cm)
Standard Deviation 4.60
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m\^2.
Outcome measures
| Measure |
Placebo Capsule
n=83 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=97 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Anthropometrics: Body Mass Index-for-age
|
17.13 Body mass index (kg/m^2)
Standard Deviation 1.53
|
17.31 Body mass index (kg/m^2)
Standard Deviation 1.28
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2.5 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m\^2.
Outcome measures
| Measure |
Placebo Capsule
n=85 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=94 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Anthropometrics: Body Mass Index-for-age
|
16.65 Body mass index (kg/m2)
Standard Deviation 1.37
|
16.92 Body mass index (kg/m2)
Standard Deviation 1.27
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m\^2.
Outcome measures
| Measure |
Placebo Capsule
n=87 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=96 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Anthropometrics: Body Mass Index-for-age
|
16.44 Body mass index (kg/m2)
Standard Deviation 1.33
|
16.67 Body mass index (kg/m2)
Standard Deviation 1.25
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3.5 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m\^2.
Outcome measures
| Measure |
Placebo Capsule
n=85 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=95 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Anthropometrics: Body Mass Index-for-age
|
16.21 Body mass index (kg/m2)
Standard Deviation 1.36
|
16.57 Body mass index (kg/m2)
Standard Deviation 1.32
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m\^2.
Outcome measures
| Measure |
Placebo Capsule
n=87 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=91 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Anthropometrics: Body Mass Index-for-age
|
16.18 Body mass index (kg/m2)
Standard Deviation 1.38
|
16.56 Body mass index (kg/m2)
Standard Deviation 1.46
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4.5 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m\^2.
Outcome measures
| Measure |
Placebo Capsule
n=86 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=91 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Anthropometrics: Body Mass Index-for-age
|
16.12 Body mass index (kg/m2)
Standard Deviation 1.51
|
16.49 Body mass index (kg/m2)
Standard Deviation 1.74
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m\^2.
Outcome measures
| Measure |
Placebo Capsule
n=83 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=88 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Anthropometrics: Body Mass Index-for-age
|
16.27 Body mass index (kg/m2)
Standard Deviation 1.83
|
16.58 Body mass index (kg/m2)
Standard Deviation 1.97
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5.5 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m\^2.
Outcome measures
| Measure |
Placebo Capsule
n=81 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=85 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Anthropometrics: Body Mass Index-for-age
|
16.46 Body mass index (kg/m2)
Standard Deviation 2.22
|
16.68 Body mass index (kg/m2)
Standard Deviation 1.95
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m\^2.
Outcome measures
| Measure |
Placebo Capsule
n=81 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=85 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Anthropometrics: Body Mass Index-for-age
|
16.57 Body mass index (kg/m2)
Standard Deviation 2.51
|
16.81 Body mass index (kg/m2)
Standard Deviation 2.27
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.
Outcome measures
| Measure |
Placebo Capsule
n=81 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=94 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Anthropometrics: Head Circumference-for-age
|
48.40 Centimeters (cm)
Standard Deviation 1.29
|
48.50 Centimeters (cm)
Standard Deviation 1.38
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2.5 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.
Outcome measures
| Measure |
Placebo Capsule
n=85 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=95 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Anthropometrics: Head Circumference-for-age
|
49.18 Centimeters (cm)
Standard Deviation 1.36
|
49.21 Centimeters (cm)
Standard Deviation 1.37
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.
Outcome measures
| Measure |
Placebo Capsule
n=87 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=97 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Anthropometrics: Head Circumference-for-age
|
49.64 Centimeters (cm)
Standard Deviation 1.34
|
49.75 Centimeters (cm)
Standard Deviation 1.34
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3.5 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.
Outcome measures
| Measure |
Placebo Capsule
n=84 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=95 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Anthropometrics: Head Circumference-for-age
|
50.05 Centimeters (cm)
Standard Deviation 1.35
|
50.15 Centimeters (cm)
Standard Deviation 1.28
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.
Outcome measures
| Measure |
Placebo Capsule
n=86 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=91 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Anthropometrics: Head Circumference-for-age
|
50.47 Centimeters (cm)
Standard Deviation 1.37
|
50.62 Centimeters (cm)
Standard Deviation 1.33
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4.5 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.
Outcome measures
| Measure |
Placebo Capsule
n=86 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=91 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Anthropometrics: Head Circumference-for-age
|
50.78 Centimeters (cm)
Standard Deviation 1.36
|
50.95 Centimeters (cm)
Standard Deviation 1.42
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.
Outcome measures
| Measure |
Placebo Capsule
n=83 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=88 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Anthropometrics: Head Circumference-for-age
|
51.04 Centimeters (cm)
Standard Deviation 1.48
|
51.37 Centimeters (cm)
Standard Deviation 1.48
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5.5 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.
Outcome measures
| Measure |
Placebo Capsule
n=81 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=84 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Anthropometrics: Head Circumference-for-age
|
51.48 Centimeters (cm)
Standard Deviation 1.42
|
51.58 Centimeters (cm)
Standard Deviation 1.42
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.
Outcome measures
| Measure |
Placebo Capsule
n=80 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=84 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Anthropometrics: Head Circumference-for-age
|
51.77 Centimeters (cm)
Standard Deviation 1.51
|
51.93 Centimeters (cm)
Standard Deviation 1.59
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 yearsPopulation: Missing data due to attrition, missed appointments, refusals or questionable intake
Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.
Outcome measures
| Measure |
Placebo Capsule
n=76 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=88 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Dietary Intake
|
1226 kilocalorie
Standard Deviation 384
|
1210 kilocalorie
Standard Deviation 439
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2.5 yearsPopulation: Missing data due to attrition, missed appointments, refusals or questionable intake
Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.
Outcome measures
| Measure |
Placebo Capsule
n=75 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=88 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Dietary Intake
|
1256 kilocalorie
Standard Deviation 413
|
1234 kilocalorie
Standard Deviation 396
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 yearsPopulation: Missing data due to attrition, missed appointments, refusals or questionable intake
Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.
Outcome measures
| Measure |
Placebo Capsule
n=74 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=90 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Dietary Intake
|
1364 kilocalorie
Standard Deviation 418
|
1285 kilocalorie
Standard Deviation 415
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3.5 yearsPopulation: Missing data due to attrition, missed appointments, refusals or questionable intake
Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.
Outcome measures
| Measure |
Placebo Capsule
n=77 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=86 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Dietary Intake
|
1340 kilocalorie
Standard Deviation 361
|
1275 kilocalorie
Standard Deviation 407
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 yearsPopulation: Missing data due to attrition, missed appointments, refusals or questionable intake
Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.
Outcome measures
| Measure |
Placebo Capsule
n=76 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=82 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Dietary Intake
|
1468 kilocalorie
Standard Deviation 472
|
1388 kilocalorie
Standard Deviation 398
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4.5 yearsPopulation: Missing data due to attrition, missed appointments, refusals or questionable intake
Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.
Outcome measures
| Measure |
Placebo Capsule
n=79 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=84 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Dietary Intake
|
1459 kilocalorie
Standard Deviation 439
|
1432 kilocalorie
Standard Deviation 423
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 yearsPopulation: Missing data due to attrition, missed appointments, refusals or questionable intake
Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.
Outcome measures
| Measure |
Placebo Capsule
n=73 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=75 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Dietary Intake
|
1412 kilocalorie
Standard Deviation 380
|
1466 kilocalorie
Standard Deviation 479
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5.5 yearsPopulation: Missing data due to attrition, missed appointments, refusals or questionable intake
Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.
Outcome measures
| Measure |
Placebo Capsule
n=64 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=73 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Dietary Intake
|
1557 kilocalorie
Standard Deviation 436
|
1532 kilocalorie
Standard Deviation 458
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 yearsPopulation: Missing data due to attrition, missed appointments, refusals or questionable intake
Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.
Outcome measures
| Measure |
Placebo Capsule
n=70 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=73 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Dietary Intake
|
1655 kilocalorie
Standard Deviation 487
|
1495 kilocalorie
Standard Deviation 469
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
Outcome measures
| Measure |
Placebo Capsule
n=78 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=86 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Systolic Blood Pressure
|
100.0 Millimeters of mercury (mmHg)
Standard Deviation 10.8
|
98.7 Millimeters of mercury (mmHg)
Standard Deviation 8.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4.5 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
Outcome measures
| Measure |
Placebo Capsule
n=81 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=85 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Systolic Blood Pressure
|
101.0 Millimeters of mercury (mmHg)
Standard Deviation 8.7
|
100.3 Millimeters of mercury (mmHg)
Standard Deviation 7.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
Outcome measures
| Measure |
Placebo Capsule
n=78 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=83 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Systolic Blood Pressure
|
99.5 Millimeters of mercury (mmHg)
Standard Deviation 7.1
|
98.2 Millimeters of mercury (mmHg)
Standard Deviation 8.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5.5 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
Outcome measures
| Measure |
Placebo Capsule
n=77 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=84 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Systolic Blood Pressure
|
102.1 Millimeters of mercury (mmHg)
Standard Deviation 8.1
|
103.5 Millimeters of mercury (mmHg)
Standard Deviation 9.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
Outcome measures
| Measure |
Placebo Capsule
n=76 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=83 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Systolic Blood Pressure
|
99.6 Millimeters of mercury (mmHg)
Standard Deviation 8.1
|
98.9 Millimeters of mercury (mmHg)
Standard Deviation 7.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
Outcome measures
| Measure |
Placebo Capsule
n=78 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=86 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Diastolic Blood Pressure
|
62.1 Millimeters of mercury (mmHg)
Standard Deviation 11.2
|
58.8 Millimeters of mercury (mmHg)
Standard Deviation 7.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4.5 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
Outcome measures
| Measure |
Placebo Capsule
n=81 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=85 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Diastolic Blood Pressure
|
63.3 Millimeters of mercury (mmHg)
Standard Deviation 9.5
|
61.0 Millimeters of mercury (mmHg)
Standard Deviation 6.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
Outcome measures
| Measure |
Placebo Capsule
n=78 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=83 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Diastolic Blood Pressure
|
58.9 Millimeters of mercury (mmHg)
Standard Deviation 5.9
|
58.3 Millimeters of mercury (mmHg)
Standard Deviation 7.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5.5 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
Outcome measures
| Measure |
Placebo Capsule
n=77 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=84 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Diastolic Blood Pressure
|
62.5 Millimeters of mercury (mmHg)
Standard Deviation 8.0
|
61.5 Millimeters of mercury (mmHg)
Standard Deviation 7.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
Outcome measures
| Measure |
Placebo Capsule
n=76 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=83 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Diastolic Blood Pressure
|
60.1 Millimeters of mercury (mmHg)
Standard Deviation 6.1
|
59.0 Millimeters of mercury (mmHg)
Standard Deviation 5.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
Outcome measures
| Measure |
Placebo Capsule
n=78 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=86 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Heart Rate
|
92.6 Beats per minute (BPM)
Standard Deviation 9.9
|
93.1 Beats per minute (BPM)
Standard Deviation 12.0
|
POST_HOC outcome
Timeframe: 5 to 5.5 years oldPopulation: Missing data due to attrition, missed appointments or refusals
Child body composition was measured between 5 and 6 years of age by BOD POD air displacement plethysmography (COSMED, Concord, CA, USA). Methods adhered to standard testing protocol (tight-fitting one-piece swimsuit and swim cap, duplicate or triplicate measure of body volume and predicted thoracic gas volume). Fat and fat free mass to the nearest 0.1 kg are presented as means with standard deviations. Normative data are not available in this pediatric population.
Outcome measures
| Measure |
Placebo Capsule
n=76 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=78 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Anthropometrics: Body Composition
Fat Mass
|
4.89 Kilogram (kg)
Standard Deviation 1.59
|
5.17 Kilogram (kg)
Standard Deviation 1.66
|
|
Anthropometrics: Body Composition
Fat Free Mass
|
14.60 Kilogram (kg)
Standard Deviation 2.31
|
15.18 Kilogram (kg)
Standard Deviation 2.10
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4.5 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
Outcome measures
| Measure |
Placebo Capsule
n=81 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=85 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Heart Rate
|
91.1 Beats per minute (BPM)
Standard Deviation 10.7
|
91.1 Beats per minute (BPM)
Standard Deviation 9.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
Outcome measures
| Measure |
Placebo Capsule
n=78 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=83 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Heart Rate
|
90.4 Beats per minute (BPM)
Standard Deviation 10.7
|
90.4 Beats per minute (BPM)
Standard Deviation 9.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5.5 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
Outcome measures
| Measure |
Placebo Capsule
n=77 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=84 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Heart Rate
|
87.9 Beats per minute (BPM)
Standard Deviation 12.4
|
87.2 Beats per minute (BPM)
Standard Deviation 11.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 yearsPopulation: Missing data due to attrition, missed appointments or refusals
Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
Outcome measures
| Measure |
Placebo Capsule
n=76 Participants
Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
|
DHA Capsule
n=83 Participants
DHA: 600 mg DHA capsule
|
|---|---|---|
|
Heart Rate
|
84.2 Beats per minute (BPM)
Standard Deviation 11
|
85.4 Beats per minute (BPM)
Standard Deviation 10.8
|
Adverse Events
Placebo Capsule
DHA Capsule
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Susan Carlson, PhD
University of Kansas Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place