Assessment of DHA On Reducing Early Preterm Birth
- Conditions
- Preterm Birth
- Interventions
- Drug: Docosahexaenoic acid - 200mg/dayDrug: Docosahexaenoic acid - 800mg/dayOther: Placebo
- Registration Number
- NCT02626299
- Lead Sponsor
- University of Kansas Medical Center
- Brief Summary
The purpose of this study is to determine if giving a larger amount of DHA than currently included in some prenatal supplements can reduce early preterm birth (birth before 34 weeks of pregnancy).
- Detailed Description
Docosahexaenoic acid (DHA) is a nutrient found in some fish and eggs and its intake in US diets is typically low. Because DHA is important for early brain development, it has recently been added to many prenatal supplements. The usual amount is around 200 mg/day. Participants in this study are guaranteed to receive at least 200 mg/day of DHA.
Almost 5 in 100 births in the US occur before 34 weeks of pregnancy. There is no way to predict which births will occur before 34 weeks. In an earlier study conducted at the University of Kansas Medical Center, women who received 600 mg DHA/day compared to no DHA had fewer births before 34 weeks of pregnancy with fewer complications of preterm birth.
This study is designed to compare standard care (200 mg/day of DHA) to a higher amount of DHA (1000 mg/day) to determine if the higher amount will reduce early preterm birth (birth before 34 weeks of pregnancy). Individual participation in this study is expected last about 5 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1100
- Pregnant females 18 years and older 12 to 20 weeks gestation at study entry
- Agree to consume study capsules and a typical prenatal supplement of 200 mg DHA
- Available by telephone
- Able to speak and read in either English or Spanish language
- Expecting multiple infants
- Gestational age at baseline <12 weeks or >20 weeks
- Unable or unwilling to agree to consume capsules until delivery
- Unwilling to discontinue use of another prenatal supplement that contains greater than or equal to 200 mg DHA per day
- Women with allergy to any component of DHA product (including algae), soybean oil or corn oil
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 200 mg/day DHA Docosahexaenoic acid - 200mg/day Participants will receive 2 placebo pills/day that do not contain DHA. Like the experimental group, they will be given a supplement of Docosahexaenoic acid - 200mg/day , a common amount in prenatal vitamins. 200 mg/day DHA Placebo Participants will receive 2 placebo pills/day that do not contain DHA. Like the experimental group, they will be given a supplement of Docosahexaenoic acid - 200mg/day , a common amount in prenatal vitamins. 1000 mg/day DHA Docosahexaenoic acid - 800mg/day The intervention includes Docosahexaenoic acid - 800mg/day per day provided in two 400 mg capsules. The intervention group as well as the active comparator group will be given 1-200 mg/capsule per day of DHA that is a common amount in prenatal vitamins. 1000 mg/day DHA Docosahexaenoic acid - 200mg/day The intervention includes Docosahexaenoic acid - 800mg/day per day provided in two 400 mg capsules. The intervention group as well as the active comparator group will be given 1-200 mg/capsule per day of DHA that is a common amount in prenatal vitamins.
- Primary Outcome Measures
Name Time Method Occurrence of Early Preterm Birth (<34 weeks gestation) Baseline to 34 weeks Bayesian posterior mean and 95% credible interval of pregnancies which result in an early preterm birth (birth before 34 weeks of pregnancy) by DHA dose and DHA status at enrollment (low/high) (modified statistical analysis plan while study was underway)
Maternal and infant adverse and serious adverse events Enrollment to 30 days past last birth Bayesian posterior mean and 95% credible interval by dose
- Secondary Outcome Measures
Name Time Method Admissiion of neonate to a neonatal intensive care unit birth Number of neonates admited to a neonatal intensive care unit by dose
Very low birth weight At birth Bayesian posterior mean and 95% credible interval \<1500 grams by dose
Preterm birth (<37 weeks) birth Number of pregnancies ending in preterm birth by dose
Pre-eclampsia 12-20 weeks gestation through birth at an average of 40 weeks Number of patients with pre-eclampsia by dose
Cesarean section birth Number of patients with c-section by dose
Maternal and infant DHA status birth Bayesian posterior mean and 95% credible interval red blood cell phospholipid DHA (weight percent of total fatty acids) at enrollment and birth by dose
Spontaneous labor birth Number of patients with spontaneous labor by dose
Low birth weight birth Bayesian posterior mean and 95% credible interval \<2500 grams by dose
Gestational age birth Bayesian posterior mean and 95% credible interval weeks gestation at birth by dose
Birth weight birth Bayesian posterior mean and 95% credible interval in grams by dose
Length and head circumference birth Bayesian posterior mean and 95% credible interval in centimeters by dose
Gestational diabetes 12-20 weeks gestation through birth at an average of 40 weeks Number of patients with gestational diabetes by dose
Trial Locations
- Locations (3)
Ohio State University
🇺🇸Columbus, Ohio, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States