drugset / Trial / NCT05949190
Improving Cognition and Gestational Duration With Targeted Nutrition
Active not recruiting
1660 enrolled
Washington University School of Medicine
Ministry of Health and Sanitation, Sierra Leone · collabOpen Philanthropy · collabProject Peanut Butter · collabUnited States Department of Agriculture (USDA) · collab
RandomizedFactorialTriple-blindTreatment
Summary
The goal of this clinical trial is to test (1) a novel maternal ready-to-use supplementary food and (2) a novel cognitive behavioral therapy intervention in undernourished Sierra Leonean women. The main questions it aims to answer are: * Will the addition of omega-3 long-chain polyunsaturated fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), as well as choline, to a maternal ready-to-use supplementary food (M-RUSF+) prolong gestation when compared with a similar supplementary food except that it lacks DHA, EPA, and choline (M-RUSF)? * Will M-RUSF+ improve infant cognitive development at 9 months of age when compared with M-RUSF? * Will the novel CBT program improve ante- and post-partum depression?
Timeline
- Start
- 2023-08-18
- Primary completion
- 2026-10
- Completion
- 2026-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Albendazole | Small molecule | 400 mg | — |
| Background | Azithromycin | Small molecule | 1 g | — |
| Background | Sulfadoxine-pyrimethamine | Small molecule | 75 mg | — |
| Background | Sulfadoxine-pyrimethamine | Small molecule | 1500 mg | — |