Assessment of DHA On Reducing Early Preterm Birth

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessment of DHA On Reducing Early Preterm Birth (ADORE Trial)

Conditions
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Preterm Birth

Intervention / Treatment
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* Drug: Docosahexaenoic acid - 800mg/day
* Drug: Docosahexaenoic acid - 200mg/day
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 200 mg/day DHA<br>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<br>* The control group will receive 1-capsule containing 200 mg DHA/d.<br>* Other names: DHA;Other: Placebo<br>* 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.<br>|
| Experimental: 1000 mg/day DHA<br>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<br>* 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)<br>* Other names: DHA;Drug: Docosahexaenoic acid - 200mg/day<br>* The control group will receive 1-capsule containing 200 mg DHA/d.<br>* Other names: DHA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Early Preterm Birth (<34 weeks gestation) | 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 | Baseline to 34 Weeks | 
| Occurrence of Early Preterm Birth (<34 weeks gestation) | 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) | Baseline to 34 weeks | 
| Maternal and infant adverse and serious adverse events | Bayesian posterior mean and 95% credible interval by dose | Enrollment to 30 days past last birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Very low birth weight | Bayesian posterior mean and 95% credible interval <1500 grams by dose | At birth | 
| Low birth weight | Bayesian posterior mean and 95% credible interval <2500 grams by dose | birth | 
| Maternal and infant DHA status | Bayesian posterior mean and 95% credible interval red blood cell phospholipid DHA (weight percent of total fatty acids) at enrollment and birth by dose | birth | 
| Gestational age | Bayesian posterior mean and 95% credible interval weeks gestation at birth by dose | birth | 
| Birth weight | Bayesian posterior mean and 95% credible interval in grams by dose | birth | 
| Length and head circumference | Bayesian posterior mean and 95% credible interval in centimeters by dose | birth | 
| Preterm birth (<37 weeks) | Bayesian posterior mean and 95% credible interval in weeks by dose | birth | 
| Preterm birth (<37 weeks) | Number of pregnancies ending in preterm birth by dose | birth | 
| Pre-eclampsia | Bayesian posterior mean and 95% credible interval | 12-20 weeks gestation through birth at an average of 40 weeks | 
| Pre-eclampsia | Number of patients with pre-eclampsia by dose | 12-20 weeks gestation through birth at an average of 40 weeks | 
| Gestational diabetes | Bayesian posterior mean and 95% credible interval by dose | 12-20 weeks gestation through birth at an average of 40 weeks | 
| Gestational diabetes | Number of patients with gestational diabetes by dose | 12-20 weeks gestation through birth at an average of 40 weeks | 
| Cesarean section | Bayesian posterior mean and 95% credible interval by dose | birth | 
| Cesarean section | Number of patients with c-section by dose | birth | 
| Spontaneous labor | Bayesian posterior mean and 95% credible interval by dose | birth | 
| Spontaneous labor | Number of patients with spontaneous labor by dose | birth | 
| Admissiion of neonate to a neonatal intensive care unit | Bayesian posterior mean and 95% credible interval by dose | birth | 
| Admissiion of neonate to a neonatal intensive care unit | Number of neonates admited to a neonatal intensive care unit by dose | birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preterm birth, Early preterm birth, Very low birth weight, Low birth weight, Pregnancy outcome, Docosahexaenoic acid (DHA), Randomized cliinical trial, Superiority trial, Adaptive design