Trial Outcomes & Findings for Improving Maternal and Child Health Through Prenatal Fatty Acid Supplementation (NCT NCT02647723)
NCT ID: NCT02647723
Last Updated: 2026-07-17
Results Overview
Will be assessed at baseline and at 24, 30, and 36 weeks of pregnancy, and at 1, 4 and 9 months after giving birth. The Perceived Stress Scale score is obtained by summing the points awarded to the 10 items and it ranges from 0 to 40 where: 0-13 - Low stress 14-26 - Moderate stress 27-40 - High perceived stress
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
168 participants
Primary outcome timeframe
16 months
Results posted on
2026-07-17
Participant Flow
Active recruitment from the University of Chicago Medical Center and affiliated Federally Qualified Health Centers (FQHC) occurred between 2016 and 2021.
Participant milestones
| Measure |
Oral Supplement for Pregnant Women
450 mg/daily of DHA beginning at 10-16 weeks of gestation through the end of pregnancy
DHA: 2 dietary supplement gel capsules providing 450 mg of DHA twice daily by oral intake for 24 weeks
|
Sugar Pill
450 mg/daily of sugar pill beginning at 10-16 weeks of gestation through the end of pregnancy
Sugar pill: 2 dietary supplement gel capsules providing 450 mg of soybean oil twice daily by oral intake for 24 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
112
|
56
|
|
Overall Study
COMPLETED
|
112
|
56
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One person from each arm did not complete the Perceived Stress Scale survey at baseline
Baseline characteristics by cohort
| Measure |
Oral Supplement for Pregnant Women
n=112 Participants
450 mg/daily of DHA beginning at 10-16 weeks of gestation through the end of pregnancy
DHA: 2 dietary supplement gel capsules providing 450 mg of DHA twice daily by oral intake for 24 weeks
|
Sugar Pill
n=56 Participants
450 mg/daily of sugar pill beginning at 10-16 weeks of gestation through the end of pregnancy
Sugar pill: 2 dietary supplement gel capsules providing 450 mg of soybean oil twice daily by oral intake for 24 weeks
|
Total
n=168 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=112 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=168 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
112 Participants
n=112 Participants
|
56 Participants
n=56 Participants
|
168 Participants
n=168 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=112 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=168 Participants
|
|
Age, Continuous
|
25.80 years
STANDARD_DEVIATION 4.27 • n=112 Participants
|
25.47 years
STANDARD_DEVIATION 4.11 • n=56 Participants
|
25.69 years
STANDARD_DEVIATION 4.21 • n=168 Participants
|
|
Sex: Female, Male
Female
|
112 Participants
n=112 Participants
|
56 Participants
n=56 Participants
|
168 Participants
n=168 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=112 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=168 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=112 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=168 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=112 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=168 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=112 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=168 Participants
|
|
Race (NIH/OMB)
Black or African American
|
112 Participants
n=112 Participants
|
56 Participants
n=56 Participants
|
168 Participants
n=168 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=112 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=168 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=112 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=168 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=112 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=168 Participants
|
|
Region of Enrollment
United States
|
112 participants
n=112 Participants
|
56 participants
n=56 Participants
|
168 participants
n=168 Participants
|
|
Perceived Stress Scale Total Score at Baseline
|
14.87 Perceived Stress Scale Total Score
STANDARD_DEVIATION 7.47 • n=111 Participants • One person from each arm did not complete the Perceived Stress Scale survey at baseline
|
17.58 Perceived Stress Scale Total Score
STANDARD_DEVIATION 8.16 • n=55 Participants • One person from each arm did not complete the Perceived Stress Scale survey at baseline
|
15.77 Perceived Stress Scale Total Score
STANDARD_DEVIATION 7.79 • n=166 Participants • One person from each arm did not complete the Perceived Stress Scale survey at baseline
|
PRIMARY outcome
Timeframe: 16 monthsPopulation: Of the 168 participants recruited, 127 had PSS data for all 4 visits.
Will be assessed at baseline and at 24, 30, and 36 weeks of pregnancy, and at 1, 4 and 9 months after giving birth. The Perceived Stress Scale score is obtained by summing the points awarded to the 10 items and it ranges from 0 to 40 where: 0-13 - Low stress 14-26 - Moderate stress 27-40 - High perceived stress
Outcome measures
| Measure |
Oral Supplement for Pregnant Women
n=86 Participants
450 mg/daily of DHA beginning at 10-16 weeks of gestation through the end of pregnancy
DHA: 2 dietary supplement gel capsules providing 450 mg of DHA twice daily by oral intake for 24 weeks
|
Sugar Pill
n=41 Participants
450 mg/daily of sugar pill beginning at 10-16 weeks of gestation through the end of pregnancy
Sugar pill: 2 dietary supplement gel capsules providing 450 mg of soybean oil twice daily by oral intake for 24 weeks
|
|---|---|---|
|
Average Change in Perceived Stress Scale (PSS) Score From Visit 1 to Visit 4
|
2.33 change in score on a scale
Standard Deviation 6.81
|
3.65 change in score on a scale
Standard Deviation 6.66
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Of the 168 participants recruited, 133 had PSS data for visits 1, 2 and 3.
Will be assessed at baseline and at 24, 30, and 36 weeks of pregnancy, and at 1, 4 and 9 months after giving birth. The Perceived Stress Scale score is obtained by summing the points awarded to the 10 items and it ranges from 0 to 40 where: 0-13 - Low stress 14-26 - Moderate stress 27-40 - High perceived stress
Outcome measures
| Measure |
Oral Supplement for Pregnant Women
n=92 Participants
450 mg/daily of DHA beginning at 10-16 weeks of gestation through the end of pregnancy
DHA: 2 dietary supplement gel capsules providing 450 mg of DHA twice daily by oral intake for 24 weeks
|
Sugar Pill
n=41 Participants
450 mg/daily of sugar pill beginning at 10-16 weeks of gestation through the end of pregnancy
Sugar pill: 2 dietary supplement gel capsules providing 450 mg of soybean oil twice daily by oral intake for 24 weeks
|
|---|---|---|
|
Average Change in Perceived Stress Scale (PSS) Score From Visit 1 to Visit 3
|
1.91 change in score on a scale
Standard Deviation 6.09
|
3.56 change in score on a scale
Standard Deviation 7.49
|
Adverse Events
Oral Supplement for Pregnant Women
Serious events: 7 serious events
Other events: 2 other events
Deaths: 0 deaths
Sugar Pill
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oral Supplement for Pregnant Women
n=112 participants at risk
450 mg/daily of DHA beginning at 10-16 weeks of gestation through the end of pregnancy
DHA: 2 dietary supplement gel capsules providing 450 mg of DHA twice daily by oral intake for 24 weeks
|
Sugar Pill
n=56 participants at risk
450 mg/daily of sugar pill beginning at 10-16 weeks of gestation through the end of pregnancy
Sugar pill: 2 dietary supplement gel capsules providing 450 mg of soybean oil twice daily by oral intake for 24 weeks
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
miscarriage
|
6.2%
7/112 • From enrollment until end of follow-up
Adverse event reporting is based on maternal self report and medical record review
|
3.6%
2/56 • From enrollment until end of follow-up
Adverse event reporting is based on maternal self report and medical record review
|
Other adverse events
| Measure |
Oral Supplement for Pregnant Women
n=112 participants at risk
450 mg/daily of DHA beginning at 10-16 weeks of gestation through the end of pregnancy
DHA: 2 dietary supplement gel capsules providing 450 mg of DHA twice daily by oral intake for 24 weeks
|
Sugar Pill
n=56 participants at risk
450 mg/daily of sugar pill beginning at 10-16 weeks of gestation through the end of pregnancy
Sugar pill: 2 dietary supplement gel capsules providing 450 mg of soybean oil twice daily by oral intake for 24 weeks
|
|---|---|---|
|
Psychiatric disorders
Anxiety in response to social stress test
|
1.8%
2/112 • From enrollment until end of follow-up
Adverse event reporting is based on maternal self report and medical record review
|
0.00%
0/56 • From enrollment until end of follow-up
Adverse event reporting is based on maternal self report and medical record review
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place