Trial Outcomes & Findings for Omega Tots: A Randomized, Controlled Trial of Long-chain Polyunsaturated Fatty Acid Supplementation of Toddler Diets and Developmental Outcomes (NCT NCT01576783)
NCT ID: NCT01576783
Last Updated: 2021-06-29
Results Overview
This outcome measure involved an examination of change in plasma and RBC fatty acid concentrations from the first study visit to the final study visit. The changes were calculated as the fatty acid level at 180 days minus the fatty acid level at baseline. Primary Outcome for 1st stage of project funded by Allen Foundation, Inc
COMPLETED
PHASE4
377 participants
Baseline to 180 days post-randomization
2021-06-29
Participant Flow
Participant milestones
| Measure |
Docosahexaenoic Acid + Arachidonic Acid
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA): 200 mg DHA+ 200 mg AA per day for 6 months
|
Placebo
Corn oil supplement
Placebo: 400 mg corn oil per day for 6 months
|
|---|---|---|
|
Overall Study
STARTED
|
189
|
188
|
|
Overall Study
COMPLETED
|
169
|
171
|
|
Overall Study
NOT COMPLETED
|
20
|
17
|
Reasons for withdrawal
| Measure |
Docosahexaenoic Acid + Arachidonic Acid
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA): 200 mg DHA+ 200 mg AA per day for 6 months
|
Placebo
Corn oil supplement
Placebo: 400 mg corn oil per day for 6 months
|
|---|---|---|
|
Overall Study
Change in Medical Care
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
14
|
16
|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
Baseline Characteristics
Omega Tots: A Randomized, Controlled Trial of Long-chain Polyunsaturated Fatty Acid Supplementation of Toddler Diets and Developmental Outcomes
Baseline characteristics by cohort
| Measure |
Docosahexaenoic Acid + Arachidonic Acid
n=189 Participants
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA): 200 mg DHA+ 200 mg AA per day for 6 months
|
Placebo
n=188 Participants
Corn oil supplement
Placebo: 400 mg corn oil per day for 6 months
|
Total
n=377 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.7 Months
n=5 Participants
|
15.6 Months
n=7 Participants
|
15.7 Months
n=5 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
105 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
182 Participants
n=5 Participants
|
178 Participants
n=7 Participants
|
360 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
52 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
114 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
236 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
21 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
189 participants
n=5 Participants
|
188 participants
n=7 Participants
|
377 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 180 days post-randomizationPopulation: Rows titles are fatty acids with different C:D ratio where, "C"= Carbohydrate; "D" = Double bond; "C:D" is the ratio of the total amount of Carbon atoms of the fatty acid in relation to the number of double (unsaturated) bonds in it. Funding allotted for 205 children to be randomized to provide blood specimens but only 173 gave pre and post samples
This outcome measure involved an examination of change in plasma and RBC fatty acid concentrations from the first study visit to the final study visit. The changes were calculated as the fatty acid level at 180 days minus the fatty acid level at baseline. Primary Outcome for 1st stage of project funded by Allen Foundation, Inc
Outcome measures
| Measure |
Docosahexaenoic Acid + Arachidonic Acid
n=85 Participants
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA): 200 mg DHA+ 200 mg AA per day for 6 months
|
Placebo
n=88 Participants
Corn oil supplement
Placebo: 400 mg corn oil per day for 6 months
|
|---|---|---|
|
Erythrocyte Fatty Acid Levels
Linoleic acid (18:2n-6)
|
-2.1 nmol/mL
Standard Deviation 5.2
|
0.6 nmol/mL
Standard Deviation 4.4
|
|
Erythrocyte Fatty Acid Levels
Arachidonic acid (20:4n-6)
|
2.0 nmol/mL
Standard Deviation 2.6
|
-0.2 nmol/mL
Standard Deviation 1.1
|
|
Erythrocyte Fatty Acid Levels
Total n-6
|
0.2 nmol/mL
Standard Deviation 6.0
|
0.4 nmol/mL
Standard Deviation 5.0
|
|
Erythrocyte Fatty Acid Levels
α-linolenic acid (18:3n-3)
|
-0.1 nmol/mL
Standard Deviation 0.4
|
0.0 nmol/mL
Standard Deviation 0.3
|
|
Erythrocyte Fatty Acid Levels
Eicosapentaenoic acid (20:5n-3)
|
0.0 nmol/mL
Standard Deviation 0.1
|
-0.1 nmol/mL
Standard Deviation 0.2
|
|
Erythrocyte Fatty Acid Levels
Docosapentaenoic acid (22:5n-3)
|
-0.1 nmol/mL
Standard Deviation 0.1
|
0.0 nmol/mL
Standard Deviation 0.1
|
|
Erythrocyte Fatty Acid Levels
Docosahexaenoic acid (22:6n-3)
|
1.1 nmol/mL
Standard Deviation 1.0
|
-0.1 nmol/mL
Standard Deviation 0.2
|
|
Erythrocyte Fatty Acid Levels
Total n-3
|
0.9 nmol/mL
Standard Deviation 1.1
|
-0.2 nmol/mL
Standard Deviation 0.5
|
PRIMARY outcome
Timeframe: Baseline to 180 days post-randomizationPopulation: Rows titles are fatty acids with different C:D ratio where, "C"= Carbohydrate; "D" = Double bond; "C:D" is the ratio of the total amount of Carbon atoms of the fatty acid in relation to the number of double (unsaturated) bonds in it. Funding allotted for 205 children to be randomized to provide blood specimens but only 173 gave pre and post samples
This outcome measure involved an examination of change in plasma and RBC fatty acid concentrations from the first study visit to the final study visit. The changes were calculated as the fatty acid level at 180 days minus the fatty acid level at baseline. Primary Outcome for 1st stage of project funded by Allen Foundation, Inc
Outcome measures
| Measure |
Docosahexaenoic Acid + Arachidonic Acid
n=85 Participants
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA): 200 mg DHA+ 200 mg AA per day for 6 months
|
Placebo
n=88 Participants
Corn oil supplement
Placebo: 400 mg corn oil per day for 6 months
|
|---|---|---|
|
Erythrocyte Fatty Acid Levels (Additional Data)
|
-3.2 ratio
Standard Deviation 3.9
|
1.6 ratio
Standard Deviation 2.8
|
PRIMARY outcome
Timeframe: Baseline to 180 days post-randomizationThe number of children who enroll in the trial and the number of those children who return for study visits 2 and 3. Primary Outcome for 1st stage of project funded by Allen Foundation, Inc.
Outcome measures
| Measure |
Docosahexaenoic Acid + Arachidonic Acid
n=189 Participants
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA): 200 mg DHA+ 200 mg AA per day for 6 months
|
Placebo
n=188 Participants
Corn oil supplement
Placebo: 400 mg corn oil per day for 6 months
|
|---|---|---|
|
Enrollment and Trial Completion
Study Visit 2 Completion
|
172 Participants
|
163 Participants
|
|
Enrollment and Trial Completion
Study Visit 3 Completion
|
166 Participants
|
168 Participants
|
PRIMARY outcome
Timeframe: Baseline to 180 days post-randomizationThe mean (average) percentage of packets consumed by the children assigned to the supplement or placebo. Primary Outcome for 1st stage of project funded by Allen Foundation, Inc
Outcome measures
| Measure |
Docosahexaenoic Acid + Arachidonic Acid
n=189 Participants
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA): 200 mg DHA+ 200 mg AA per day for 6 months
|
Placebo
n=188 Participants
Corn oil supplement
Placebo: 400 mg corn oil per day for 6 months
|
|---|---|---|
|
Adherence
|
80.6 average percentage of packets consumed
Standard Deviation 28
|
80.7 average percentage of packets consumed
Standard Deviation 25
|
SECONDARY outcome
Timeframe: Baseline to 180 days post-randomizationInfant Behavior Questionnaire-Revised (IBQ-R; short form) was used to assess effortful control (12 items) and activity level (3 items). The IBQ-R measures early temperament-based inhibitory control,a key component of executive function as children mature. Scores range from 1 to 7, with higher scores indicating greater frequency of behaviors. IBQ-R scores were measured at baseline and then again at study completion (180 days post randomization). The scores were calculated as a change between two time points (the IBQ-R value at 180 days minus the IBQ-R value at baseline).
Outcome measures
| Measure |
Docosahexaenoic Acid + Arachidonic Acid
n=189 Participants
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA): 200 mg DHA+ 200 mg AA per day for 6 months
|
Placebo
n=188 Participants
Corn oil supplement
Placebo: 400 mg corn oil per day for 6 months
|
|---|---|---|
|
(Behavior) Infant Behavior Questionnaire-Revised (IBQ-R; Short Form)
Effortful Control
|
-0.7 units on a scale
Standard Deviation 0.8
|
-0.5 units on a scale
Standard Deviation 0.8
|
|
(Behavior) Infant Behavior Questionnaire-Revised (IBQ-R; Short Form)
Activity Level
|
0.6 units on a scale
Standard Deviation 1.5
|
0.5 units on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Baseline to 180 days post-randomizationBayley Scales of Infant and Toddler Development, third edition, (Bayley-III) is an instrument designed to measure the developmental functioning of infants and toddlers between the ages of 1 month and 42 months (age adjustments for prematurity are accommodated with the tool). It provides age specific composite scores for cognitive (91 items,score min 55 max 145), language (98 items, score min 47 max 153), and motor (138 items, score min 46 max 154) skills. For all scales, higher scores are better and lower scores indicate possible delay/deficit. Bayley-III scores were measured at baseline and then again at study completion (180 days post randomization). The scores were calculated as a change between two time points (the Bayley-III value at 180 days minus the Bayley-III value at baseline). Secondary Outcome for 1st stage of project funded by Allen Foundation, Inc; Primary Outcome for 2nd stage of project funded by March of Dimes and Health Resources and Services Administration
Outcome measures
| Measure |
Docosahexaenoic Acid + Arachidonic Acid
n=189 Participants
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA): 200 mg DHA+ 200 mg AA per day for 6 months
|
Placebo
n=188 Participants
Corn oil supplement
Placebo: 400 mg corn oil per day for 6 months
|
|---|---|---|
|
(Development) Bayley Scales of Infant and Toddler Development, Third Edition(Bayley-III)
Cognitive Composite
|
-2.6 units on a scale
Standard Deviation 13.3
|
-3.7 units on a scale
Standard Deviation 12.2
|
|
(Development) Bayley Scales of Infant and Toddler Development, Third Edition(Bayley-III)
Language Composite
|
-0.5 units on a scale
Standard Deviation 12.0
|
0.2 units on a scale
Standard Deviation 12.6
|
|
(Development) Bayley Scales of Infant and Toddler Development, Third Edition(Bayley-III)
Motor Composite
|
-0.6 units on a scale
Standard Deviation 12.5
|
-0.4 units on a scale
Standard Deviation 12.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 180 days post-randomizationThe following sleep characteristics were captured based on caregiver-report: nocturnal sleep duration (hours), daytime sleep duration (hours), total sleep duration within a 24-hour period (hours). Larger values represent more time spent in each type of sleep. BISQ scores were measured at baseline and then again at study completion (180 days post randomization). The scores were calculated as a change between two time points (the BISQ value at 180 days minus the BISQ value at baseline).
Outcome measures
| Measure |
Docosahexaenoic Acid + Arachidonic Acid
n=189 Participants
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA): 200 mg DHA+ 200 mg AA per day for 6 months
|
Placebo
n=188 Participants
Corn oil supplement
Placebo: 400 mg corn oil per day for 6 months
|
|---|---|---|
|
Brief Infant Sleep Questionnaire (BISQ)
Nocturnal Sleep Duration
|
0.25 hours
Standard Deviation 1.61
|
-0.16 hours
Standard Deviation 1.34
|
|
Brief Infant Sleep Questionnaire (BISQ)
Daytime Sleep Duration
|
-0.32 hours
Standard Deviation 1.15
|
-0.46 hours
Standard Deviation 1.25
|
|
Brief Infant Sleep Questionnaire (BISQ)
Total Sleep Duration
|
-0.07 hours
Standard Deviation 2.22
|
-0.57 hours
Standard Deviation 1.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 180 days post-randomizationChanges in body composition from baseline to 6 months post-randomization (weight, recumbent length, head circumference, mid-upper arm circumference, triceps and subscapular skinfolds). These measurements were converted to z scores for corrected age based on Child Growth Standards from the World Health Organization. The z-score indicates the number of standard deviations away from the mean. A z score of 0 is equal to the mean of a reference population (children the same age and sex). Values less than 0 indicate values lower than the reference population, while values greater than 0 indicate values higher than the reference population.
Outcome measures
| Measure |
Docosahexaenoic Acid + Arachidonic Acid
n=189 Participants
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA): 200 mg DHA+ 200 mg AA per day for 6 months
|
Placebo
n=188 Participants
Corn oil supplement
Placebo: 400 mg corn oil per day for 6 months
|
|---|---|---|
|
Body Composition
Weight
|
0.1 z scores
Standard Deviation 0.4
|
0.0 z scores
Standard Deviation 0.4
|
|
Body Composition
Recumbent Length
|
0.1 z scores
Standard Deviation 0.9
|
0.2 z scores
Standard Deviation 0.9
|
|
Body Composition
Head Circumference
|
-0.0 z scores
Standard Deviation 0.6
|
-0.1 z scores
Standard Deviation 0.5
|
|
Body Composition
Mid-Upper Arm Circumference
|
0.0 z scores
Standard Deviation 0.8
|
0.1 z scores
Standard Deviation 0.7
|
|
Body Composition
Triceps Skinfold
|
-0.0 z scores
Standard Deviation 0.7
|
-0.1 z scores
Standard Deviation 0.8
|
|
Body Composition
Subscapular Skinfold
|
-0.2 z scores
Standard Deviation 0.8
|
-0.2 z scores
Standard Deviation 0.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 180 days post-randomizationPopulation: The number analyzed for the competence and ASD scales differs from the overall number analyzed due to missing data on these two scales.
BITSEA measures socioemotional development in toddlerhood. Scores were summed to provide competence (range: 0-22) and problem (range: 0-62) scores, respectively. The problem scale is further divided into subscales: externalizing (6 items; range: 0-12), internalizing (8 items; range: 0-16), and dysregulation (8 items; range: 0-16). Additionally, 14 items comprise a red flag scale (range: 0-28). Eight items from the competence and nine items from the problem subscales are indicative of behaviors often seen in children with ASD. Each of the 17 ASD items was dichotomized to illustrate the presence (1) (i.e., competence items absent, problem items present) or absence (0) (i.e., competence items present, problem items absent) of each ASD behavior. Items were then summed to derive an ASD score (range: 0-17). Higher competence scores represent better functioning, whereas higher problem (including the problem subscales), red flag, and ASD scores were indicative of poorer functioning.
Outcome measures
| Measure |
Docosahexaenoic Acid + Arachidonic Acid
n=161 Participants
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA): 200 mg DHA+ 200 mg AA per day for 6 months
|
Placebo
n=153 Participants
Corn oil supplement
Placebo: 400 mg corn oil per day for 6 months
|
|---|---|---|
|
Brief Infant Toddler Social Emotional Assessment (BITSEA)
ASD
|
4.11 units on a scale
Standard Deviation 2.29
|
4.36 units on a scale
Standard Deviation 2.98
|
|
Brief Infant Toddler Social Emotional Assessment (BITSEA)
Competence
|
16.50 units on a scale
Standard Deviation 3.09
|
16.73 units on a scale
Standard Deviation 2.94
|
|
Brief Infant Toddler Social Emotional Assessment (BITSEA)
Problem
|
9.81 units on a scale
Standard Deviation 6.01
|
10.18 units on a scale
Standard Deviation 6.84
|
|
Brief Infant Toddler Social Emotional Assessment (BITSEA)
Externalizing
|
2.29 units on a scale
Standard Deviation 2.06
|
2.30 units on a scale
Standard Deviation 1.98
|
|
Brief Infant Toddler Social Emotional Assessment (BITSEA)
Internalizing
|
2.04 units on a scale
Standard Deviation 1.58
|
2.31 units on a scale
Standard Deviation 2.10
|
|
Brief Infant Toddler Social Emotional Assessment (BITSEA)
Dysregulation
|
3.25 units on a scale
Standard Deviation 2.57
|
3.29 units on a scale
Standard Deviation 2.59
|
|
Brief Infant Toddler Social Emotional Assessment (BITSEA)
Red Flag
|
2.93 units on a scale
Standard Deviation 2.48
|
3.12 units on a scale
Standard Deviation 2.85
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 180 days post-randomizationThe PDDST-II is a clinically derived, caregiver-completed screener to assist in differentiating an ASD diagnosis from other disorders in children with developmental concerns, including those born preterm. The PDDST-II comprised 14 yes/no items that indicate the presence (1) or absence (0) of developmental concerns. Items were summed (possible range: 0-14) and higher scores represented greater developmental concern.
Outcome measures
| Measure |
Docosahexaenoic Acid + Arachidonic Acid
n=160 Participants
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA): 200 mg DHA+ 200 mg AA per day for 6 months
|
Placebo
n=153 Participants
Corn oil supplement
Placebo: 400 mg corn oil per day for 6 months
|
|---|---|---|
|
Pervasive Developmental Disorders Screening Test - II, Stage 2 (PDDST-II)
|
2.91 units on a scale
Standard Deviation 2.35
|
3.37 units on a scale
Standard Deviation 3.02
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Long-term effect (approximately 8 months) after intervention completionLong-term (26-32 months of age) outcomes. This will be evaluated using scores on the Brief Infant Sleep Questionnaire (BISQ).The following sleep characteristics were captured based on caregiver-report: nocturnal sleep duration (hours), daytime sleep duration (hours), total sleep duration within a 24-hour period (hours). Larger values represent more time spent in each type of sleep. BISQ scores were measured at baseline and then again at post-intervention follow-up (approximately 8 months after the trial ended). The scores were calculated as a change between two time points (the BISQ value at post-intervention follow-up minus the BISQ value at baseline).
Outcome measures
| Measure |
Docosahexaenoic Acid + Arachidonic Acid
n=136 Participants
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA): 200 mg DHA+ 200 mg AA per day for 6 months
|
Placebo
n=125 Participants
Corn oil supplement
Placebo: 400 mg corn oil per day for 6 months
|
|---|---|---|
|
Other Long-term Outcomes: Sleep (BISQ)
Total Sleep Duration
|
-0.57 hours
Standard Deviation 2.20
|
-1.17 hours
Standard Deviation 1.85
|
|
Other Long-term Outcomes: Sleep (BISQ)
Nocturnal Sleep Duration
|
-0.11 hours
Standard Deviation 1.68
|
-0.38 hours
Standard Deviation 1.43
|
|
Other Long-term Outcomes: Sleep (BISQ)
Daytime Sleep Duration
|
-0.46 hours
Standard Deviation 1.30
|
-0.81 hours
Standard Deviation 1.41
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Long-term effect (approximately 8 months) after intervention completionLong-term (26-32 months of age) outcomes. This will be evaluated using the total score on a subset of 13 items from the Children's Sleep Habits Questionnaire (CSHQ). The range in total score is 13-39. A higher score is indicative of more sleep problems.
Outcome measures
| Measure |
Docosahexaenoic Acid + Arachidonic Acid
n=134 Participants
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA): 200 mg DHA+ 200 mg AA per day for 6 months
|
Placebo
n=122 Participants
Corn oil supplement
Placebo: 400 mg corn oil per day for 6 months
|
|---|---|---|
|
Other Long-term Outcomes: Sleep (CSHQ)
|
18.82 units on a scale
Standard Deviation 4.96
|
19.57 units on a scale
Standard Deviation 5.40
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Long-term effect (approximately 8 months) after intervention completionLong-term (26-32 months of age) cognitive outcome. This will be evaluated based on standard scores from the cognitive section of the Developmental Profile - 3. The range in standard scores is 40-140 with higher scores represent better cognitive ability.
Outcome measures
| Measure |
Docosahexaenoic Acid + Arachidonic Acid
n=134 Participants
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA): 200 mg DHA+ 200 mg AA per day for 6 months
|
Placebo
n=120 Participants
Corn oil supplement
Placebo: 400 mg corn oil per day for 6 months
|
|---|---|---|
|
Long-term Efficacy in Improving Cognition
|
103.36 units on a scale
Standard Deviation 19.00
|
107.93 units on a scale
Standard Deviation 19.93
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Long-term effect (approximately 8 months) after intervention completionLong-term (26-32 months of age) executive function outcomes. This will be evaluated using scores on the Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P). The BRIEF-P yields five clinical scales, each measuring a different aspect of executive function: inhibit, shift, emotional control, working memory, and plan/organize. The clinical scales merge to create four broad indices of executive function: inhibitory self-control, flexibility, emergent metacognition, and global executive composite. A t-score of 50 is equal to the population mean with scores below 50 indicating better executive function, and scores above 50 indicating worse executive function for each reported aspect.
Outcome measures
| Measure |
Docosahexaenoic Acid + Arachidonic Acid
n=115 Participants
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA): 200 mg DHA+ 200 mg AA per day for 6 months
|
Placebo
n=104 Participants
Corn oil supplement
Placebo: 400 mg corn oil per day for 6 months
|
|---|---|---|
|
Long-term Efficacy in Improving Executive Functions (BRIEF-P)
Emotional Control
|
48.55 units on a scale
Standard Deviation 8.20
|
49.98 units on a scale
Standard Deviation 9.33
|
|
Long-term Efficacy in Improving Executive Functions (BRIEF-P)
Working Memory
|
53.79 units on a scale
Standard Deviation 11.30
|
56.04 units on a scale
Standard Deviation 13.63
|
|
Long-term Efficacy in Improving Executive Functions (BRIEF-P)
Plan/Organize
|
49.66 units on a scale
Standard Deviation 10.58
|
52.69 units on a scale
Standard Deviation 12.02
|
|
Long-term Efficacy in Improving Executive Functions (BRIEF-P)
Emergent Metacognition Index
|
52.17 units on a scale
Standard Deviation 11.27
|
55.01 units on a scale
Standard Deviation 13.76
|
|
Long-term Efficacy in Improving Executive Functions (BRIEF-P)
Global Executive Composite
|
50.09 units on a scale
Standard Deviation 10.60
|
52.67 units on a scale
Standard Deviation 12.51
|
|
Long-term Efficacy in Improving Executive Functions (BRIEF-P)
Inhibit
|
50.20 units on a scale
Standard Deviation 10.69
|
51.91 units on a scale
Standard Deviation 10.57
|
|
Long-term Efficacy in Improving Executive Functions (BRIEF-P)
Shift
|
47.08 units on a scale
Standard Deviation 8.89
|
49.16 units on a scale
Standard Deviation 9.92
|
|
Long-term Efficacy in Improving Executive Functions (BRIEF-P)
Inhibitory Self-control Index
|
49.44 units on a scale
Standard Deviation 9.44
|
51.13 units on a scale
Standard Deviation 10.23
|
|
Long-term Efficacy in Improving Executive Functions (BRIEF-P)
Flexibility Index
|
47.62 units on a scale
Standard Deviation 8.72
|
49.60 units on a scale
Standard Deviation 9.88
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Long-term effect (approximately 8 months) after intervention completionLong-term (26-32 months of age) executive function outcomes. This will be evaluated using scores on the Attention Deficit/Hyperactivity Problems DSM oriented subscale and the Attention syndrome subscale of the Child Behavior Checklist 1.5-5 (CBCL). A t-score of 50 is equal to the population mean with scores below 50 indicating less behavioral problems, and scores above 50 indicating more behavioral problems.
Outcome measures
| Measure |
Docosahexaenoic Acid + Arachidonic Acid
n=136 Participants
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA): 200 mg DHA+ 200 mg AA per day for 6 months
|
Placebo
n=125 Participants
Corn oil supplement
Placebo: 400 mg corn oil per day for 6 months
|
|---|---|---|
|
Long-term Efficacy in Improving Executive Functions (CBCL)
Attention Deficit/Hyperactivity Problems
|
55.04 t-score
Standard Deviation 6.90
|
55.08 t-score
Standard Deviation 6.43
|
|
Long-term Efficacy in Improving Executive Functions (CBCL)
Attention Problems
|
55.21 t-score
Standard Deviation 7.10
|
55.71 t-score
Standard Deviation 6.82
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Long-term effect (approximately 8 months) after intervention completionLong-term (26-32 months of age) outcomes. This will be evaluated using scores on the Pervasive Developmental Problems DSM oriented scale on the Child Behavior Checklist 1.5-5 (CBCL). A t-score of 50 is equal to the population mean with scores below 50 indicating less problems and scores above 50 indicating more problems.
Outcome measures
| Measure |
Docosahexaenoic Acid + Arachidonic Acid
n=136 Participants
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA): 200 mg DHA+ 200 mg AA per day for 6 months
|
Placebo
n=125 Participants
Corn oil supplement
Placebo: 400 mg corn oil per day for 6 months
|
|---|---|---|
|
Other Long-term Outcomes: Pervasive Developmental Problems
|
53.76 t-score
Standard Deviation 6.12
|
55.54 t-score
Standard Deviation 7.78
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Long-term effect (approximately 8 months) after intervention completionLong-term (26-32 months of age) outcomes. This will be evaluated using scores on the Communicative Development Inventory (CDI). On this measure, caregivers selected the number of words from a list of 100 common words that their child used. Scores reflect the total number of words, from the list of 100, that the child used.
Outcome measures
| Measure |
Docosahexaenoic Acid + Arachidonic Acid
n=136 Participants
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA): 200 mg DHA+ 200 mg AA per day for 6 months
|
Placebo
n=124 Participants
Corn oil supplement
Placebo: 400 mg corn oil per day for 6 months
|
|---|---|---|
|
Other Long-term Outcomes: Language
|
56.68 words
Standard Deviation 28.75
|
61.15 words
Standard Deviation 27.94
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Long-term effect (approximately 8 months) after intervention completionLong-term (26-32 months of age) outcomes. This will be evaluated using caregiver reports/diagnoses of developmental delay.
Outcome measures
| Measure |
Docosahexaenoic Acid + Arachidonic Acid
n=133 Participants
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA): 200 mg DHA+ 200 mg AA per day for 6 months
|
Placebo
n=116 Participants
Corn oil supplement
Placebo: 400 mg corn oil per day for 6 months
|
|---|---|---|
|
Other Long-term Outcomes: Number of Participants With Developmental Delay
|
30 Participants
|
18 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Long-term effect (approximately 8 months) after intervention completionLong-term (26-32 months of age) outcomes. This will be evaluated using caregiver reports/diagnoses of behavioral difficulties.
Outcome measures
| Measure |
Docosahexaenoic Acid + Arachidonic Acid
n=133 Participants
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA): 200 mg DHA+ 200 mg AA per day for 6 months
|
Placebo
n=116 Participants
Corn oil supplement
Placebo: 400 mg corn oil per day for 6 months
|
|---|---|---|
|
Other Long-term Outcomes: Number of Participants With Behavior Difficulties
|
5 Participants
|
1 Participants
|
Adverse Events
Docosahexaenoic Acid + Arachidonic Acid
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Docosahexaenoic Acid + Arachidonic Acid
n=189 participants at risk
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA): 200 mg DHA+ 200 mg AA per day for 6 months
|
Placebo
n=188 participants at risk
Corn oil supplement
Placebo: 400 mg corn oil per day for 6 months
|
|---|---|---|
|
Ear and labyrinth disorders
ENT Symptoms
|
15.3%
29/189 • Baseline to 180 days post randomization
Information to be collected includes event description, time of onset, Study Doctor's assessment of severity, relationship to study product,and time of resolution/stabilization of the event. All AEs occurring during study participation must be documented appropriately regardless of relationship. Adverse Events were monitored/assessed and classified by body or organ system.
|
17.6%
33/188 • Baseline to 180 days post randomization
Information to be collected includes event description, time of onset, Study Doctor's assessment of severity, relationship to study product,and time of resolution/stabilization of the event. All AEs occurring during study participation must be documented appropriately regardless of relationship. Adverse Events were monitored/assessed and classified by body or organ system.
|
|
Gastrointestinal disorders
Gastrointestinal Symptoms
|
36.5%
69/189 • Baseline to 180 days post randomization
Information to be collected includes event description, time of onset, Study Doctor's assessment of severity, relationship to study product,and time of resolution/stabilization of the event. All AEs occurring during study participation must be documented appropriately regardless of relationship. Adverse Events were monitored/assessed and classified by body or organ system.
|
33.5%
63/188 • Baseline to 180 days post randomization
Information to be collected includes event description, time of onset, Study Doctor's assessment of severity, relationship to study product,and time of resolution/stabilization of the event. All AEs occurring during study participation must be documented appropriately regardless of relationship. Adverse Events were monitored/assessed and classified by body or organ system.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory symptoms
|
12.2%
23/189 • Baseline to 180 days post randomization
Information to be collected includes event description, time of onset, Study Doctor's assessment of severity, relationship to study product,and time of resolution/stabilization of the event. All AEs occurring during study participation must be documented appropriately regardless of relationship. Adverse Events were monitored/assessed and classified by body or organ system.
|
11.7%
22/188 • Baseline to 180 days post randomization
Information to be collected includes event description, time of onset, Study Doctor's assessment of severity, relationship to study product,and time of resolution/stabilization of the event. All AEs occurring during study participation must be documented appropriately regardless of relationship. Adverse Events were monitored/assessed and classified by body or organ system.
|
|
Skin and subcutaneous tissue disorders
Skin/Limb Symptoms
|
6.3%
12/189 • Baseline to 180 days post randomization
Information to be collected includes event description, time of onset, Study Doctor's assessment of severity, relationship to study product,and time of resolution/stabilization of the event. All AEs occurring during study participation must be documented appropriately regardless of relationship. Adverse Events were monitored/assessed and classified by body or organ system.
|
9.6%
18/188 • Baseline to 180 days post randomization
Information to be collected includes event description, time of onset, Study Doctor's assessment of severity, relationship to study product,and time of resolution/stabilization of the event. All AEs occurring during study participation must be documented appropriately regardless of relationship. Adverse Events were monitored/assessed and classified by body or organ system.
|
|
Social circumstances
Behavioral Symptoms
|
11.6%
22/189 • Baseline to 180 days post randomization
Information to be collected includes event description, time of onset, Study Doctor's assessment of severity, relationship to study product,and time of resolution/stabilization of the event. All AEs occurring during study participation must be documented appropriately regardless of relationship. Adverse Events were monitored/assessed and classified by body or organ system.
|
10.1%
19/188 • Baseline to 180 days post randomization
Information to be collected includes event description, time of onset, Study Doctor's assessment of severity, relationship to study product,and time of resolution/stabilization of the event. All AEs occurring during study participation must be documented appropriately regardless of relationship. Adverse Events were monitored/assessed and classified by body or organ system.
|
|
Immune system disorders
Misc Symptoms
|
18.5%
35/189 • Baseline to 180 days post randomization
Information to be collected includes event description, time of onset, Study Doctor's assessment of severity, relationship to study product,and time of resolution/stabilization of the event. All AEs occurring during study participation must be documented appropriately regardless of relationship. Adverse Events were monitored/assessed and classified by body or organ system.
|
21.8%
41/188 • Baseline to 180 days post randomization
Information to be collected includes event description, time of onset, Study Doctor's assessment of severity, relationship to study product,and time of resolution/stabilization of the event. All AEs occurring during study participation must be documented appropriately regardless of relationship. Adverse Events were monitored/assessed and classified by body or organ system.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place