Improving Maternal and Child Health Through Prenatal Fatty Acid Supplementation

Study Results

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Pregnancy Child Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Oral supplement for pregnant women

450 mg/daily of DHA beginning at 10-16 weeks of gestation through the end of pregnancy

Group Type EXPERIMENTAL

DHA

Intervention Type DIETARY_SUPPLEMENT

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

Group Type PLACEBO_COMPARATOR

Sugar pill

Intervention Type DIETARY_SUPPLEMENT

2 dietary supplement gel capsules providing 450 mg of soybean oil twice daily by oral intake for 24 weeks

Interventions

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DHA

2 dietary supplement gel capsules providing 450 mg of DHA twice daily by oral intake for 24 weeks

Intervention Type DIETARY_SUPPLEMENT

Sugar pill

2 dietary supplement gel capsules providing 450 mg of soybean oil twice daily by oral intake for 24 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Omega-3 docosahexaenoic acid soybean oil

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

34 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes