Kansas University DHA Outcome Study (KUDOS) Follow-Up

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2016-05-31

Brief Summary

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This is a continuation study to KUDOS (NCT00266825). The purpose of this study is to follow-up with participants on the original study to determine if the effects of increasing DHA intake during pregnancy increase cognitive development in 2 to 6 year-old children.

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Detailed Description

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Numerous trials show benefits of postnatal DHA supplementation for visual acuity. There are also numerous observational(not intervention)studies that link higher maternal DHA status during pregnancy to higher cognitive function. Intervention studies that increase DHA exposure during fetal life and that measure cognitive development of infants are lacking; and no study to date has systematically followed children whose mothers were randomly assigned to DHA supplementation to school age with regular 6 month assessments of age-appropriate assessments of cognitive development. The absence of such studies is a serious limitation because there is evidence that differences in cognitive function due to such interventions do not become robust until around age 4 years. Women in the US consume low amounts of DHA compared to other world populations, and this likely means less DHA transfer to the fetus than in many other populations. Prenatal DHA exposure may be more important than postnatal exposure, because animal studies show critical windows for brain DHA accumulation in relation to effects on neurotransmitters such as serotonin, dopamine and GABA.

Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo Capsule

Group Type PLACEBO_COMPARATOR

Placebo Capsule

Intervention Type DRUG

600 mg of Soybean Oil and Corn Oil, which does not contain any DHA

DHA Capsule

Group Type EXPERIMENTAL

DHA

Intervention Type DRUG

600 mg DHA capsule

Interventions

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DHA

600 mg DHA capsule

Intervention Type DRUG

Placebo Capsule

600 mg of Soybean Oil and Corn Oil, which does not contain any DHA

Intervention Type DRUG

Other Intervention Names

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docosahexaenoic acid

Eligibility Criteria

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Inclusion Criteria

* Pregnant females 16.0-35.0 years of age (inclusive) at 8-20 weeks gestation at enrollment (date/ultrasound)
* Agree to consume study capsules from enrollment until delivery
* Agree to return to the study center for delivery
* BMI \< 40
* No serious illnesses (e.g., cancer, diabetes, lupus, hepatitis, sexually transmitted diseases, not HIV positive)
* Available by telephone

Exclusion Criteria

* Less than 16 or greater than 35 years of age
* BMI \< 40
* Serious illness such as cancer, lupus, hepatitis, sexually transmitted disease or HIV positive
* Expecting multiple infants
* Diabetes or gestational diabetes at baseline
* Elevated blood pressure due to any cause
* Not planning to return to the study center for delivery
* Gestational age at baseline \< 8 weeks or \>20 weeks
* Unable or unwilling to agree to consume capsules until delivery
* Unable to provide informed consent in English

Minimum Eligible Age

16 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes