Clinical trial NCT01007110: Effects of Docosahexaenoic Acid (DHA) on Fetal Cardiac Outcomes
Official title: The Effects of Docosahexaenoic Acid (DHA) on Fetal Cardiac Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pregnancy
Keywords: DHA
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2009-11-03
Enrollment: 67
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.

Detailed 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.

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 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

Primary outcomes:
measure: Heart Rate
timeFrame: 24, 32 and 36 weeks gestational age
Secondary outcomes:
measure: Neonatal Behavioral Assessment Scale (NBAS) Scores
timeFrame: within 2 weeks of delivery
measure: Maternal Red Blood Cell (RBC) Phospholipids at Delivery
timeFrame: Time of delivery, 36 weeks to term
measure: Cord Blood Phospholipids DHA
timeFrame: Birth
measure: Cardiac Conduction Time
timeFrame: Change from Baseline to 2 Months Post-natal
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Kathleen Gustafson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gustafson KM, Carlson SE, Colombo J, Yeh HW, Shaddy DJ, Li S, Kerling EH. Effects of docosahexaenoic acid supplementation during pregnancy on fetal heart rate and variability: a randomized clinical trial. Prostaglandins Leukot Essent Fatty Acids. 2013 May;88(5):331-8. doi: 10.1016/j.plefa.2013.01.009. Epub 2013 Feb 20.
citation: Christifano DN, Taylor MK, Carlson SE, Colombo J, Gustafson KM. Higher maternal weight is related to poorer fetal autonomic function. J Dev Orig Health Dis. 2021 Jun;12(3):354-356. doi: 10.1017/S2040174420000653. Epub 2020 Jul 14.
citation: Hoyer D, Schmidt A, Gustafson KM, Lobmaier SM, Lakhno I, van Leeuwen P, Cysarz D, Preisl H, Schneider U. Heart rate variability categories of fluctuation amplitude and complexity: diagnostic markers of fetal development and its disturbances. Physiol Meas. 2019 Jul 3;40(6):064002. doi: 10.1088/1361-6579/ab205f.