Trial Outcomes & Findings for DHA Supplementation and Pregnancy Outcome (NCT NCT00266825)
NCT ID: NCT00266825
Last Updated: 2016-03-14
Results Overview
Measure of RBC-phospholipid-DHA at Birth
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
350 participants
Primary outcome timeframe
at time of birth
Results posted on
2016-03-14
Participant Flow
Participants recruited from the Kansas City metro area. Enrollment occurred between January 2006 and November 2009.
Participant milestones
| Measure |
Placebo Capsule
Placebo capsule
Placebo capsule: Placebo capsule
|
DHA Supplement
DHA capsule
DHA: 600 mg DHA
|
|---|---|---|
|
Enrolled and Allocated Intervention
STARTED
|
172
|
178
|
|
Enrolled and Allocated Intervention
COMPLETED
|
172
|
178
|
|
Enrolled and Allocated Intervention
NOT COMPLETED
|
0
|
0
|
|
Completed Follow-Up
STARTED
|
172
|
178
|
|
Completed Follow-Up
COMPLETED
|
147
|
154
|
|
Completed Follow-Up
NOT COMPLETED
|
25
|
24
|
Reasons for withdrawal
| Measure |
Placebo Capsule
Placebo capsule
Placebo capsule: Placebo capsule
|
DHA Supplement
DHA capsule
DHA: 600 mg DHA
|
|---|---|---|
|
Completed Follow-Up
Lost to Follow-up
|
14
|
19
|
|
Completed Follow-Up
Withdrawal by Subject
|
11
|
5
|
Baseline Characteristics
DHA Supplementation and Pregnancy Outcome
Baseline characteristics by cohort
| Measure |
Placebo Capsule
n=172 Participants
Placebo capsule
Placebo capsule: Placebo capsule
|
DHA Supplement
n=178 Participants
DHA capsule
DHA: 600 mg DHA
|
Total
n=350 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
24.8 years
STANDARD_DEVIATION 4.7 • n=5 Participants
|
25.3 years
STANDARD_DEVIATION 4.9 • n=7 Participants
|
25.0 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
172 Participants
n=5 Participants
|
178 Participants
n=7 Participants
|
350 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
79 participants
n=5 Participants
|
66 participants
n=7 Participants
|
145 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Black
|
93 participants
n=5 Participants
|
112 participants
n=7 Participants
|
205 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic
|
158 participants
n=5 Participants
|
164 participants
n=7 Participants
|
322 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
172 participants
n=5 Participants
|
178 participants
n=7 Participants
|
350 participants
n=5 Participants
|
|
Gestation at Enrollment
|
99.6 days
STANDARD_DEVIATION 26.1 • n=5 Participants
|
102.9 days
STANDARD_DEVIATION 25.3 • n=7 Participants
|
101.3 days
STANDARD_DEVIATION 25.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: at time of birthPopulation: The effect of DHA supplementation on study primary outcomes was determined for black and non-black subjects separately. Researchers did not compare outcomes between black and non-black subjects to determine whether they were statistically different. For measures reporting black and non-black results, there were 184 non-black and 117 black subjects.
Measure of RBC-phospholipid-DHA at Birth
Outcome measures
| Measure |
Placebo Capsule
n=147 Participants
Placebo capsule
Placebo capsule: Placebo capsule
|
DHA Supplement
n=154 Participants
DHA capsule
DHA: 600 mg DHA
|
|---|---|---|
|
Percentage of Total Fatty Acids by Weight
All Subjects
|
4.7 percentage of fatty acid
Standard Deviation 1.3
|
7.3 percentage of fatty acid
Standard Deviation 2.2
|
|
Percentage of Total Fatty Acids by Weight
Not Black Subjects (n=93, 112))
|
4.8 percentage of fatty acid
Standard Deviation 1.3
|
7.8 percentage of fatty acid
Standard Deviation 2.1
|
|
Percentage of Total Fatty Acids by Weight
Black Subjects (n=79, 66)
|
4.7 percentage of fatty acid
Standard Deviation 1.3
|
6.2 percentage of fatty acid
Standard Deviation 2.0
|
PRIMARY outcome
Timeframe: at time of birthPopulation: The effect of DHA supplementation on study primary outcomes was determined for black and non-black subjects separately. Researchers did not compare outcomes between black and non-black subjects to determine whether they were statistically different. For measures reporting black and non-black results, there were 184 non-black and 117 black subjects.
Gestational age of babies at time of birth in days
Outcome measures
| Measure |
Placebo Capsule
n=147 Participants
Placebo capsule
Placebo capsule: Placebo capsule
|
DHA Supplement
n=154 Participants
DHA capsule
DHA: 600 mg DHA
|
|---|---|---|
|
Gestational Age
All Subjects
|
272.8 days
Standard Deviation 17.0
|
275.7 days
Standard Deviation 11.2
|
|
Gestational Age
Not Black Subjects (n=93,112)
|
273.8 days
Standard Deviation 14.0
|
275.9 days
Standard Deviation 9.9
|
|
Gestational Age
Black Subjects (n=79,66)
|
271.4 days
Standard Deviation 20.3
|
275.2 days
Standard Deviation 13.3
|
PRIMARY outcome
Timeframe: at time of birthPopulation: The effect of DHA supplementation on study primary outcomes was determined for black and non-black subjects separately. Researchers did not compare outcomes between black and non-black subjects to determine whether they were statistically different. For measures reporting black and non-black results, there were 184 non-black and 117 black subjects.
Weight of baby at birth
Outcome measures
| Measure |
Placebo Capsule
n=147 Participants
Placebo capsule
Placebo capsule: Placebo capsule
|
DHA Supplement
n=154 Participants
DHA capsule
DHA: 600 mg DHA
|
|---|---|---|
|
Birth Weight
All Subjects
|
3187 grams
Standard Deviation 602
|
3359 grams
Standard Deviation 524
|
|
Birth Weight
Not Black Subjects (n=93,112)
|
3282 grams
Standard Deviation 529
|
3489 grams
Standard Deviation 456
|
|
Birth Weight
Black Subjects (n=79,66)
|
3060 grams
Standard Deviation 671
|
3110 grams
Standard Deviation 559
|
PRIMARY outcome
Timeframe: at time of birthPopulation: The effect of DHA supplementation on study primary outcomes was determined for black and non-black subjects separately. Researchers did not compare outcomes between black and non-black subjects to determine whether they were statistically different. For measures reporting black and non-black results, there were 184 non-black and 117 black subjects.
Length of baby at birth
Outcome measures
| Measure |
Placebo Capsule
n=147 Participants
Placebo capsule
Placebo capsule: Placebo capsule
|
DHA Supplement
n=154 Participants
DHA capsule
DHA: 600 mg DHA
|
|---|---|---|
|
Birth Length
Not Black Subjects (n=93,112)
|
49.2 centimeters
Standard Deviation 2.9
|
50.0 centimeters
Standard Deviation 2.6
|
|
Birth Length
Black Subjects (n=79,66)
|
48.6 centimeters
Standard Deviation 4.0
|
49.0 centimeters
Standard Deviation 2.7
|
|
Birth Length
All Subjects
|
49.0 centimeters
Standard Deviation 3.4
|
49.7 centimeters
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: at time of birthPonderal index calculated with formula Weight (g)/length (cm)\^3 \* 100. It a measure of leanness of a person and is calculated as a relationship between mass and height. Commonly used in pediatrics.
Outcome measures
| Measure |
Placebo Capsule
n=147 Participants
Placebo capsule
Placebo capsule: Placebo capsule
|
DHA Supplement
n=154 Participants
DHA capsule
DHA: 600 mg DHA
|
|---|---|---|
|
Ponderal Index
|
2.7 units on a scale
Standard Deviation 0.4
|
2.7 units on a scale
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: at time of birthOutcome measures
| Measure |
Placebo Capsule
n=147 Participants
Placebo capsule
Placebo capsule: Placebo capsule
|
DHA Supplement
n=154 Participants
DHA capsule
DHA: 600 mg DHA
|
|---|---|---|
|
Gender of Babies
Male
|
54 percentage of babies
|
49 percentage of babies
|
|
Gender of Babies
Female
|
46 percentage of babies
|
51 percentage of babies
|
SECONDARY outcome
Timeframe: at time of birthPercentage of total fatty acids by weight in cord RBC
Outcome measures
| Measure |
Placebo Capsule
n=147 Participants
Placebo capsule
Placebo capsule: Placebo capsule
|
DHA Supplement
n=154 Participants
DHA capsule
DHA: 600 mg DHA
|
|---|---|---|
|
Cord RBC-phospholipid-DHA
|
5.9 percentage of cord RBC
Standard Deviation 1.4
|
7.3 percentage of cord RBC
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: at time of birthMeasure of circumference of baby's head in centimeters at time of birth.
Outcome measures
| Measure |
Placebo Capsule
n=147 Participants
Placebo capsule
Placebo capsule: Placebo capsule
|
DHA Supplement
n=154 Participants
DHA capsule
DHA: 600 mg DHA
|
|---|---|---|
|
Head Circumference
|
33.7 centimeters
Standard Deviation 2.0
|
34.2 centimeters
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: births before week 37 of gestationPercentage of births occurring at less than 37 weeks of gestation.
Outcome measures
| Measure |
Placebo Capsule
n=147 Participants
Placebo capsule
Placebo capsule: Placebo capsule
|
DHA Supplement
n=154 Participants
DHA capsule
DHA: 600 mg DHA
|
|---|---|---|
|
Preterm Births
|
8.8 percentage of births
|
7.8 percentage of births
|
Adverse Events
Placebo Capsule - Mother
Serious events: 18 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Capsule - Infant
Serious events: 31 serious events
Other events: 0 other events
Deaths: 0 deaths
DHA Capsule - Mother
Serious events: 18 serious events
Other events: 0 other events
Deaths: 0 deaths
DHA Capsule - Infant
Serious events: 26 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Capsule - Mother
n=147 participants at risk
Placebo capsule
Placebo capsule: Placebo capsule
|
Placebo Capsule - Infant
n=147 participants at risk
Infants born from Mothers in the Placebo capsule group
|
DHA Capsule - Mother
n=154 participants at risk
DHA capsule
DHA: 600 mg DHA
|
DHA Capsule - Infant
n=154 participants at risk
Infants born from Mothers in the DHA capsule group
|
|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Hospitalization or miscarriage
|
12.2%
18/147 • Number of events 18 • Researchers followed the mother for 30 days post-partum and the infant from birth to 18 months. Typical follow-up stops 30 days after the end of the intervention. Researchers collected information on each from their medical records.
|
—
0/0 • Researchers followed the mother for 30 days post-partum and the infant from birth to 18 months. Typical follow-up stops 30 days after the end of the intervention. Researchers collected information on each from their medical records.
|
11.7%
18/154 • Number of events 18 • Researchers followed the mother for 30 days post-partum and the infant from birth to 18 months. Typical follow-up stops 30 days after the end of the intervention. Researchers collected information on each from their medical records.
|
—
0/0 • Researchers followed the mother for 30 days post-partum and the infant from birth to 18 months. Typical follow-up stops 30 days after the end of the intervention. Researchers collected information on each from their medical records.
|
|
Pregnancy, puerperium and perinatal conditions
Hospitalization and death
|
—
0/0 • Researchers followed the mother for 30 days post-partum and the infant from birth to 18 months. Typical follow-up stops 30 days after the end of the intervention. Researchers collected information on each from their medical records.
|
21.1%
31/147 • Number of events 31 • Researchers followed the mother for 30 days post-partum and the infant from birth to 18 months. Typical follow-up stops 30 days after the end of the intervention. Researchers collected information on each from their medical records.
|
—
0/0 • Researchers followed the mother for 30 days post-partum and the infant from birth to 18 months. Typical follow-up stops 30 days after the end of the intervention. Researchers collected information on each from their medical records.
|
16.9%
26/154 • Number of events 26 • Researchers followed the mother for 30 days post-partum and the infant from birth to 18 months. Typical follow-up stops 30 days after the end of the intervention. Researchers collected information on each from their medical records.
|
|
Congenital, familial and genetic disorders
Congenital anomalies
|
—
0/0 • Researchers followed the mother for 30 days post-partum and the infant from birth to 18 months. Typical follow-up stops 30 days after the end of the intervention. Researchers collected information on each from their medical records.
|
1.4%
2/147 • Number of events 2 • Researchers followed the mother for 30 days post-partum and the infant from birth to 18 months. Typical follow-up stops 30 days after the end of the intervention. Researchers collected information on each from their medical records.
|
—
0/0 • Researchers followed the mother for 30 days post-partum and the infant from birth to 18 months. Typical follow-up stops 30 days after the end of the intervention. Researchers collected information on each from their medical records.
|
3.2%
5/154 • Number of events 5 • Researchers followed the mother for 30 days post-partum and the infant from birth to 18 months. Typical follow-up stops 30 days after the end of the intervention. Researchers collected information on each from their medical records.
|
|
Pregnancy, puerperium and perinatal conditions
Postpartum hospitalization
|
2.0%
3/147 • Number of events 3 • Researchers followed the mother for 30 days post-partum and the infant from birth to 18 months. Typical follow-up stops 30 days after the end of the intervention. Researchers collected information on each from their medical records.
|
—
0/0 • Researchers followed the mother for 30 days post-partum and the infant from birth to 18 months. Typical follow-up stops 30 days after the end of the intervention. Researchers collected information on each from their medical records.
|
0.65%
1/154 • Number of events 1 • Researchers followed the mother for 30 days post-partum and the infant from birth to 18 months. Typical follow-up stops 30 days after the end of the intervention. Researchers collected information on each from their medical records.
|
—
0/0 • Researchers followed the mother for 30 days post-partum and the infant from birth to 18 months. Typical follow-up stops 30 days after the end of the intervention. Researchers collected information on each from their medical records.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place