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ACTIVE NOT RECRUITING
NCT05949190
NA

Improving Cognition and Gestational Duration With Targeted Nutrition

Sponsor: Washington University School of Medicine

View on ClinicalTrials.gov

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

Interventions

DIETARY_SUPPLEMENT

M-RUSF+ (Maternal Ready-to-Use Supplementary Food + DHA/EPA/choline)

Balanced energy protein supplement with added DHA/EPA/choline, micronutrients

DIETARY_SUPPLEMENT

M-RUSF (Maternal Ready-to-Use Supplementary Food)

Balanced energy protein supplement with added micronutrients

DRUG

Azithromycin

1g dose

DRUG

Albendazole

400mg dose

DRUG

Sulfadoxine pyrimethamine

Monthly, 1,500/75mg dose

BEHAVIORAL

Cognitive behavioral therapy

Novel program developed for illiterate end-users

OTHER

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