Effects of Docosahexaenoic Acid (DHA) on Fetal Cardiac Outcomes

Kansas Board of Regents

Status and phase: Completed; Phase 3

Conditions: Pregnancy

Treatments: Other: Placebo; Dietary Supplement: DHA

Study type: Interventional

Funder types: Other

Identifiers

NCT01007110

11625 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 67 patients

Sex: Female

Ages: 16 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

67 participants in 2 patient groups, including a placebo group

Docosahexaenoic Acid (DHA)

Active Comparator group

Description:

Docosahexaenoic Acid (DHA)

Treatment:

Dietary Supplement: DHA

Placebo

Placebo Comparator group

Description:

soy/corn oil placebo

Treatment:

Other: Placebo