Phase 3
N=67
Effects of Docosahexaenoic Acid (DHA) on Fetal Cardiac Outcomes
Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT01007110 ↗Enrolled (actual)
67
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: Heart Rate — 146.0; 145.2; 142.5; 140.8 Beats per minute
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- DHA (Dietary_supplement); Placebo (Other)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- Female
- Sponsor
- University of Kansas
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Heart Rate |
146.0; 145.2; 142.5; 140.8; 145.0; 141.7 | — |
| SECONDARY Neonatal Behavioral Assessment Scale (NBAS) Scores |
9.92; 8.47; 19.75; 23.40; 23.08; 26.07 | — |
| SECONDARY Maternal Red Blood Cell (RBC) Phospholipids at Delivery |
4.99; 7.09 | — |
| SECONDARY Cord Blood Phospholipids DHA |
6.18; 7.75 | — |
| SECONDARY Cardiac Conduction Time |
38.98; 39.49 | — |
Summary
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.
Eligibility Criteria
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
- 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 20 weeks
- Unable to provide informed consent in English
Data sourced from ClinicalTrials.gov (NCT01007110). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.