Clinical Research Directory
Browse clinical research sites, groups, and studies.
Improving Cognition and Gestational Duration With Targeted Nutrition
Sponsor: Washington University School of Medicine
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?
Key Details
Gender
All
Age Range
13 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1660
Start Date
2023-08-18
Completion Date
2026-10
Last Updated
2026-03-02
Healthy Volunteers
No
Conditions
Interventions
M-RUSF+ (Maternal Ready-to-Use Supplementary Food + DHA/EPA/choline)
Balanced energy protein supplement with added DHA/EPA/choline, micronutrients
M-RUSF (Maternal Ready-to-Use Supplementary Food)
Balanced energy protein supplement with added micronutrients
Azithromycin
1g dose
Albendazole
400mg dose
Sulfadoxine pyrimethamine
Monthly, 1,500/75mg dose
Cognitive behavioral therapy
Novel program developed for illiterate end-users
Insecticide-treated mosquito net
Bed net to prevent malaria
Locations (10)
Bandajuma
Bandajuma, Southern Province, Sierra Leone
Bendu Malen
Bendu, Southern Province, Sierra Leone
Blama Massaquoi
Blama Massaquoi, Southern Province, Sierra Leone
Futa Peje
Futa Peje, Southern Province, Sierra Leone
Gbondapi
Gbondapi, Southern Province, Sierra Leone
Nyandehun Malen
Nyandehun, Southern Province, Sierra Leone
Potoru
Potoru, Southern Province, Sierra Leone
Pujehun Static
Pujehun, Southern Province, Sierra Leone
Sahn Malen
Sahn, Southern Province, Sierra Leone
Zimmi
Zimmi, Southern Province, Sierra Leone