Effects of Docosahexaenoic Acid (DHA) on Fetal Cardiac Outcomes

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2011-07-31

Brief Summary

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DHA, a type of fatty acid, is important in early development, both in terms of reproductive physiology of gestation and in postnatal behavioral and cognitive function. In adults, DHA has been shown to lower triglycerides and is important to cardiovascular health and autonomic control, lowering heart rate and blood pressure and increasing heart variability. Little is known about how fatty acids impact cardiac control in infants, children or the fetus. Our hypothesis is that maternal DHA supplementation (600 mg/day) will lower fetal HR and increase fetal HRV.

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Detailed Description

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We have observed that maternal DHA supplementation during pregnancy results in lower fetal heart rate (HR) and higher heart-rate variability (HRV). In another study, we found that infants on DHA supplemented formula have lower HR. Because DHA supplementation in infancy is associated with improved neurobehavioral outcomes and infants with lower HR and higher vagal control have been found to have improved developmental outcomes, the first aim is to conduct a randomized, placebo-controlled trial to determine whether maternal DHA supplementation during pregnancy results in lower HR and higher HRV in the fetal period. We will document other fetal neurobehaviors (body and breathing movements) as they are hallmarks of fetal well-being and influence HR and HRV.

Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Docosahexaenoic Acid (DHA)

Group Type ACTIVE_COMPARATOR

DHA

Intervention Type DIETARY_SUPPLEMENT

Docosahexaenoic Acid (DHA) from algal oil

Placebo

soy/corn oil placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo capsule

Interventions

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DHA

Docosahexaenoic Acid (DHA) from algal oil

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo capsule

Intervention Type OTHER

Other Intervention Names

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Docosahexaenoic acid Algal oil

Eligibility Criteria

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Inclusion Criteria

* Pregnant females 16.0-35.99 years of age who are 12 to 20 weeks gestation at the time of enrollment (by dates or ultrasound)
* Agree to consume study capsules from enrollment until delivery
* BMI \<40 at baseline or weight does not exceed 300 pounds
* No serious illnesses likely to confound study outcomes
* Available by phone

Exclusion Criteria

* Less than 16 or greater than 35.99 years of age at enrollment
* BMI \>40 at baseline
* Any serious illness likely to confound primary study outcomes
* Expecting multiple infants
* Diabetes (Type I, II or gestational) at baseline
* Elevated blood pressure due to any cause (systolic BP \>= 140 mm Hg
* Gestational age at baseline \< 12 weeks or \> 20 weeks
* Unable to provide informed consent in English

Minimum Eligible Age

16 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No