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Prenatal DHA and Neurofunctional Development

NCT ID: NCT02709239

Last Updated: 2021-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-01

Study Completion Date

2021-08-16

Brief Summary

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The purpose of this study is to learn how much DHA to give to mothers in order to provide enough to the baby. Researchers will also learn if there are differences in development of the baby up to 12 months after birth.

Detailed Description

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Docosahexaenoic acid (DHA) is an essential nutrient. Our bodies make DHA from the foods we eat. If we eat foods with a lot of DHA, like fatty ocean fish, we have more DHA in our bodies. DHA is found in all cells of the body but is especially high in nerve cells of the brain and eye. Babies get DHA from the mother when they're in the womb. After birth, they can get DHA from breast milk or infant formulas.

This study will enroll pregnant women and follow them and their baby until the baby is 12 months old. Changes in the development of the baby will be tracked. Half of the participants in this study will receive 200mg of DHA to take daily. The other half of participants will receive 800mg of DHA to take daily. Participants, along with the researchers, will not know which dose of DHA they are receiving.

Conditions

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Use and Dose of Prenatal DHA Supplementation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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DHA 200mg

Participants will receive 200mg DHA to take per day. Participants will be asked to take four capsules containing 50mg DHA each.

Group Type ACTIVE_COMPARATOR

DHA 200mg

Intervention Type DIETARY_SUPPLEMENT

4 50mg capsules of DHA to be taken by mouth daily

DHA 800mg

Participants will receive 800mg DHA to take per day. Participants will be asked to take four capsules containing 200mg DHA each.

Group Type EXPERIMENTAL

DHA 800mg

Intervention Type DIETARY_SUPPLEMENT

4 200mg capsules of DHA to be taken by mouth daily

Interventions

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DHA 200mg

4 50mg capsules of DHA to be taken by mouth daily

Intervention Type DIETARY_SUPPLEMENT

DHA 800mg

4 200mg capsules of DHA to be taken by mouth daily

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Docosahexaenoic Acid Docosahexaenoic Acid

Eligibility Criteria

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Inclusion Criteria

* Women in their 12th to 20th week of gestation
* Participants agree to consume the study capsules from enrollment to delivery
* Healthy weight, overweight and obese women (determined by body mass index; BMI) are eligible
* Must be available by telephone

Exclusion Criteria

* Underweight women and women who exceed 250 lbs at enrollment
* Women with serious systemic infection, cancer, major organ disease or systemic lupus erythematosus
* Women with multiple infants or fetal diagnosis of congenital cardiac structural or conduction defects or brain malformations
* Diagnosis of Type I diabetes, and/or hypertension
* Reported drug and/or alcohol abuse
* Unwilling to take capsules, or be contacted by phone
* Do not understand English
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathleen Gustafson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

References

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Gustafson KM, Christifano DN, Hoyer D, Schmidt A, Carlson SE, Colombo J, Mathis NB, Sands SA, Chollet-Hinton L, Brown AR, Mudaranthakam DP, Gajewski BJ. Prenatal docosahexaenoic acid effect on maternal-infant DHA-equilibrium and fetal neurodevelopment: a randomized clinical trial. Pediatr Res. 2022 Jul;92(1):255-264. doi: 10.1038/s41390-021-01742-w. Epub 2021 Sep 22.

Reference Type RESULT
PMID: 34552200 (View on PubMed)

Christifano DN, Chollet-Hinton L, Hoyer D, Schmidt A, Gustafson KM. Intake of eggs, choline, lutein, zeaxanthin, and DHA during pregnancy and their relationship to fetal neurodevelopment. Nutr Neurosci. 2023 Aug;26(8):749-755. doi: 10.1080/1028415X.2022.2088944. Epub 2022 Jun 17.

Reference Type DERIVED
PMID: 35715980 (View on PubMed)

Other Identifiers

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1R01HD086001

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00003792

Identifier Type: -

Identifier Source: org_study_id