Improving Maternal and Child Health Through Prenatal Fatty Acid Supplementation

Not Applicable

Active, not recruiting

• Conditions: Pregnancy; Child Development
• Interventions: Dietary Supplement: DHA; Dietary Supplement: Sugar pill

• Registration Number: NCT02647723
• Lead Sponsor: University of Chicago

Brief Summary

The purpose of the study is to test whether nutritional supplementation during pregnancy is associated with 1) improved maternal health during pregnancy; 2) improved infant birth and neurodevelopmental outcomes, and 3) whether the association between nutritional supplementation during pregnancy and infant outcomes is partially mediated by reductions in maternal perceived stress and stress reactivity during pregnancy.

Detailed Description

Low-income pregnant women often experience chronic stress and consequently higher levels of stress hormones. In utero exposure to high levels of stress hormones can negatively affect the developing fetus and the infant's capacity for emotion and behavioral regulation. This program of research is designed to reduce the negative impact of prenatal stress on infant health and development via nutritional supplementation of docosahexaenoic acid (DHA) during pregnancy. DHA is a long-chain polyunsaturated fatty acid member of the omega-3 fatty acid family. DHA is found in its highest concentrations in neural cell membranes, affecting receptor function, neurotransmitter uptake, and signal transmission. There is growing evidence that low levels of dietary DHA intake are associated with suboptimal response to stress and that DHA supplementation can modulate stress response.

One hundred sixty-two pregnant women will be randomly assigned to receive 450 mg/daily of DHA or placebo beginning at 9-12 weeks of gestation through the end of pregnancy. Perceived stress, stressful life events, anxiety, and depression, inflammatory markers, DHA levels and response to a laboratory stressor will be assessed at baseline and at 24, 30, and 36 weeks of pregnancy. Neonatal outcomes (e.g., gestational age, birth weight, delivery complications) will be collected from medical records, and infant neurodevelopmental outcomes and stress reactivity will be assessed at 1, 4 and 9 months of age. Coded data will be analyzed by the Investigators at University of Chicago and University of Pittsburgh

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-04
• Study First Submitted QC: 2016-01-04
• Study First Posted: 2016-01-06
• Status Verified: 2024-05
• Results First Submitted: 2024-05-15
• Results First Submitted QC: 2024-06-28
• Last Update Submitted: 2024-06-28
• Results First Posted: 2024-07-25
• Last Update Posted: 2024-07-25
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 168

Inclusion Criteria

• Age between 18 and 34
• Household recipient of public assistance (e.g. Medicaid insurance) due to low income
• Low levels of DHA consumption as defined as less than two fish servings per week

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Exclusion Criteria

• Reports of known medial complications
• Regular use of steroid medications, alcohol, cigarettes, or illegal substances (by maternal report)
• Use of blood thinners or anti-coagulants
• Use of psychotropic medications
• Allergy to iodine and/or soy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral supplement for pregnant women	DHA	450 mg/daily of DHA beginning at 10-16 weeks of gestation through the end of pregnancy
Sugar pill	Sugar pill	450 mg/daily of sugar pill beginning at 10-16 weeks of gestation through the end of pregnancy

Primary Outcome Measures

Name	Time	Method
Average Change in Perceived Stress Scale (PSS) Score From Visit 1 to Visit 4	16 months	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
Average Change in Perceived Stress Scale (PSS) Score From Visit 1 to Visit 3	12 months	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

Trial Locations

Locations (1)

University of Chicago Medicine; 🇺🇸 Chicago, Illinois, United States