DHA Supplementation and Pregnancy Outcome

NCT ID: NCT02219399

Last Updated: 2014-08-18

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

871 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2014-01-31

Brief Summary

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Supplementation with DHA during pregnancy will increase gestational length and improve cognitive development.

Detailed Description

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This was a trial of supplementation with DHA during pregnancy to increase gestational length. Subjects were provided with 300 mg, 600 mg or placebo (olive oil) in a randomized design from week 24-26 of pregnancy until delivery. Gestational age, birth weight and birth length data were collected and infants growth at 2 and 4 months and cognitive development at 4 months and 1 year were measured.

Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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300 mg DHA

300 mg DHA

Group Type EXPERIMENTAL

300 mg DHA

Intervention Type DIETARY_SUPPLEMENT

Pregnant women were given 300 mg DHA in the last trimester of pregnancy and through the first 3 months of breastfeeding

Placebo

olive oil or high oleic acid sunflower oil placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Pregnant women in the control group received placebo of either olive oil or high oleic acid sunflower oil during the study period

600 mg DHA

600 mg DHA

Group Type EXPERIMENTAL

600 mg DHA

Intervention Type DIETARY_SUPPLEMENT

Pregnant women were given 600 mg DHA in the last trimester of pregnancy

Interventions

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600 mg DHA

Pregnant women were given 600 mg DHA in the last trimester of pregnancy

Intervention Type DIETARY_SUPPLEMENT

300 mg DHA

Pregnant women were given 300 mg DHA in the last trimester of pregnancy and through the first 3 months of breastfeeding

Intervention Type DIETARY_SUPPLEMENT

Placebo

Pregnant women in the control group received placebo of either olive oil or high oleic acid sunflower oil during the study period

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* singleton pregnancy
* 18 years of age or older

Exclusion Criteria

* cervical incompetence
* presence of cervical cerclage
* placenta previa
* intrauterine infection
* known substance abuse
* multiple fetuses
* current pre-eclampsia
* preexisting diabetes
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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USDA Beltsville Human Nutrition Research Center

FED

Sponsor Role collaborator

Colorado State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mary A Harris, PhD

Role: PRINCIPAL_INVESTIGATOR

Colorado State University

Locations

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Denver Health Hospitals and Clinics

Denver, Colorado, United States

Site Status

Colorado State University

Fort Collins, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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00186H

Identifier Type: -

Identifier Source: org_study_id

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