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Trial Outcomes & Findings for Improving Maternal and Child Health Through Prenatal Fatty Acid Supplementation (NCT NCT02647723)

NCT ID: NCT02647723

Last Updated: 2025-04-22

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

2025-04-22

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

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

Improving Maternal and Child Health Through Prenatal Fatty Acid Supplementation

Baseline characteristics by cohort

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=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
112 Participants
n=5 Participants
56 Participants
n=7 Participants
168 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
25.80 years
STANDARD_DEVIATION 4.27 • n=5 Participants
25.47 years
STANDARD_DEVIATION 4.11 • n=7 Participants
25.69 years
STANDARD_DEVIATION 4.21 • n=5 Participants
Sex: Female, Male
Female
112 Participants
n=5 Participants
56 Participants
n=7 Participants
168 Participants
n=5 Participants
Sex: Female, Male
Male
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
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 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
112 Participants
n=5 Participants
56 Participants
n=7 Participants
168 Participants
n=5 Participants
Race (NIH/OMB)
White
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 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
112 participants
n=5 Participants
56 participants
n=7 Participants
168 participants
n=5 Participants

PRIMARY outcome

Timeframe: 16 months

Population: 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

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 months

Population: 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

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: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Sugar Pill

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kate Keenan

University of Chicago

Phone: 773-702-4449

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place