ADORE: Assessment of DHA On Reducing Early Preterm Birth
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: 200 mg/day DHA 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. |
Drug: Docosahexaenoic acid - 200mg/day
The control group will receive 1-capsule containing 200 mg DHA/d.
Other Names:
Other: Placebo
Participants will receive 2 capsules (masked) containing half soybean oil and half corn oil equaling 800 mg.The soybean and corn oil combination does not contain DHA.
|
| Experimental: 1000 mg/day DHA 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. |
Drug: Docosahexaenoic acid - 800mg/day
All participants will take 1000 mg/DHA per day (1 capsule will be labeled with 200 mg; 2 capsules will be masked with 400 mg each)
Other Names:
Drug: Docosahexaenoic acid - 200mg/day
The control group will receive 1-capsule containing 200 mg DHA/d.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- Very low birth weight [At birth]
Bayesian posterior mean and 95% credible interval <1500 grams by dose
- Low birth weight [birth]
Bayesian posterior mean and 95% credible interval <2500 grams 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
- 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
- Preterm birth (<37 weeks) [birth]
Bayesian posterior mean and 95% credible interval in weeks 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]
Bayesian posterior mean and 95% credible interval
- Pre-eclampsia [12-20 weeks gestation through birth at an average of 40 weeks]
Number of patients with pre-eclampsia by dose
- Gestational diabetes [12-20 weeks gestation through birth at an average of 40 weeks]
Bayesian posterior mean and 95% credible interval by dose
- Gestational diabetes [12-20 weeks gestation through birth at an average of 40 weeks]
Number of patients with gestational diabetes by dose
- Cesarean section [birth]
Bayesian posterior mean and 95% credible interval by dose
- Cesarean section [birth]
Number of patients with c-section by dose
- Spontaneous labor [birth]
Bayesian posterior mean and 95% credible interval by dose
- Spontaneous labor [birth]
Number of patients with spontaneous labor by dose
- Admissiion of neonate to a neonatal intensive care unit [birth]
Bayesian posterior mean and 95% credible interval by dose
- Admissiion of neonate to a neonatal intensive care unit [birth]
Number of neonates admited to a neonatal intensive care unit by dose
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
Exclusion Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Kansas Medical Center | Kansas City | Kansas | United States | 66160 |
| 2 | University of Cincinnati | Cincinnati | Ohio | United States | 45220 |
| 3 | Ohio State University | Columbus | Ohio | United States | 43210 |
Sponsors and Collaborators
- University of Kansas Medical Center
- University of Cincinnati
- Ohio State University
- Nationwide Children's Hospital
Investigators
- Principal Investigator: Susan E. Carlson, PhD, University of Kansas Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00003455