drugset / Trial / NCT02626299
Assessment of DHA On Reducing Early Preterm Birth
Phase 3
Completed
1100 enrolled
University of Kansas Medical Center
Nationwide Children's Hospital · collabOhio State University · collabUniversity of Cincinnati · collab
RandomizedParallel-groupQuadruple-blindPrevention
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).
Timeline
- Start
- 2016-06-08
- Primary completion
- 2020-10-05
- Completion
- 2020-10-05
Publications
- Wang Y, Gajewski BJ, Valentine CJ, Crawford SA, Brown AR, Mudaranthakam DP, Camargo JT, Carlson SE. DHA, nutrient intake, and maternal characteristics as predictors of pregnancy outcomes in a randomised clinical trial of DHA supplementation. Clin Nutr. 2023 Nov;42(11):2229-2240. doi: 10.1016/j.clnu.2023.09.005. Epub 2023 Sep 20.
- Carlson SE, Gajewski BJ, Valentine CJ, Sands SA, Brown AR, Kerling EH, Crawford SA, Buhimschi CS, Weiner CP, Cackovic M, DeFranco EA, Mudaranthakam DP, Rogers LK. Early and late preterm birth rates in participants adherent to randomly assigned high dose docosahexaenoic acid (DHA) supplementation in pregnancy. Clin Nutr. 2023 Feb;42(2):235-243. doi: 10.1016/j.clnu.2023.01.009. Epub 2023 Jan 11.
- Mudaranthakam DP, Brown A, Kerling E, Carlson SE, Valentine CJ, Gajewski B. The Successful Synchronized Orchestration of an Investigator-Initiated Multicenter Trial Using a Clinical Trial Management System and Team Approach: Design and Utility Study. JMIR Form Res. 2021 Dec 22;5(12):e30368. doi: 10.2196/30368.
- Carlson SE, Gajewski BJ, Valentine CJ, Kerling EH, Weiner CP, Cackovic M, Buhimschi CS, Rogers LK, Sands SA, Brown AR, Mudaranthakam DP, Crawford SA, DeFranco EA. Higher dose docosahexaenoic acid supplementation during pregnancy and early preterm birth: A randomised, double-blind, adaptive-design superiority trial. EClinicalMedicine. 2021 May 17;36:100905. doi: 10.1016/j.eclinm.2021.100905. eCollection 2021 Jun.
- Carlson SE, Gajewski BJ, Valentine CJ, Rogers LK, Weiner CP, DeFranco EA, Buhimschi CS. Assessment of DHA on reducing early preterm birth: the ADORE randomized controlled trial protocol. BMC Pregnancy Childbirth. 2017 Feb 13;17(1):62. doi: 10.1186/s12884-017-1244-5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DOCONEXENT | Other / unclassified | 200 mg | — |
| Subject | DOCONEXENT | Other / unclassified | 800 mg | — |
Indications
No indication recorded.