Docosahexaenoic acid - 800mg/day
DrugAll 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: DHA
NCT Number: NCT02626299
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).
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Notify Me18 year and older
Female
Interventional
Phase 3
University of Kansas Medical Center, Kansas City, Kansas, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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: DHA
The control group will receive 1-capsule containing 200 mg DHA/d.
Other names: DHA
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.
Time frame: 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
Time frame: 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)
Time frame: Enrollment to 30 days past last birth
Bayesian posterior mean and 95% credible interval by dose
Time frame: At birth
Bayesian posterior mean and 95% credible interval <1500 grams by dose
Time frame: birth
Bayesian posterior mean and 95% credible interval <2500 grams by dose
Time frame: 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
Time frame: birth
Bayesian posterior mean and 95% credible interval weeks gestation at birth by dose
Time frame: birth
Bayesian posterior mean and 95% credible interval in grams by dose
Time frame: birth
Bayesian posterior mean and 95% credible interval in centimeters by dose
Time frame: birth
Bayesian posterior mean and 95% credible interval in weeks by dose
Time frame: birth
Number of pregnancies ending in preterm birth by dose
Time frame: 12-20 weeks gestation through birth at an average of 40 weeks
Bayesian posterior mean and 95% credible interval
Time frame: 12-20 weeks gestation through birth at an average of 40 weeks
Number of patients with pre-eclampsia by dose
Time frame: 12-20 weeks gestation through birth at an average of 40 weeks
Bayesian posterior mean and 95% credible interval by dose
Time frame: 12-20 weeks gestation through birth at an average of 40 weeks
Number of patients with gestational diabetes by dose
Time frame: birth
Bayesian posterior mean and 95% credible interval by dose
Time frame: birth
Number of patients with c-section by dose
Time frame: birth
Bayesian posterior mean and 95% credible interval by dose
Time frame: birth
Number of patients with spontaneous labor by dose
Time frame: birth
Bayesian posterior mean and 95% credible interval by dose
Time frame: birth
Number of neonates admited to a neonatal intensive care unit by dose
University of Kansas Medical Center
Other
Assessment of DHA On Reducing Early Preterm Birth (ADORE Trial)
Acronym: ADORE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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