Effects of Docosahexaenoic Acid (DHA) on Fetal Cardiac Outcomes
Completed · Phase 3 · Has a placebo group
Conditions studied: Pregnancy
In brief
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.
Key facts
- Study ID
- NCT01007110
- Run by
- University of Kansas
- People needed
- 67
- Starts
- 2009-05-01
- Expected to finish
- 2011-07-01
- Last updated by the study team
- 2014-06-09
Who can join
Age: 16 and older, up to 35. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Kansas Medical Center — Kansas City, Kansas, United States
Full record on ClinicalTrials.gov
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