CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 132 enrolled
Drug / intervention
hydroxyurea (20mg/kg/day) +1 moredrug
Likely dose
hydroxyurea (20mg/kg/day)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03634488
NCT03634488Phase 2Completed

Management of Severe Acute Malnutrition in Children With Sickle Cell Disease Greater Than 5 Years of Age Living in Northern Nigeria

Vanderbilt University Medical Center·interventional·Posted Aug 16, 2018·Updated Mar 27, 2024

In Brief

A Phase 2 clinical trial evaluating hydroxyurea (20mg/kg/day) and Ready-to-use therapeutic food for Sickle Cell Anemia and Severe Acute Malnutrition. Completed, enrolled 132 participants across 3 sites in 2 countries.

Detailed Summary

Except for children with HIV, all recommendations for treatment of childhood malnutrition are for children \< 5 years of age. The overall goal of this randomized controlled nutrition feasibility trial is to identify whether families of children with sickle cell disease (SCD) 5 years and older agree to participate over a 12-week period. The investigators will also establish a safety protocol for monitoring potential complications associated with treating severe malnutrition in children 5 years and older with and without SCD, in a low-resource setting.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNigeria, United States

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedAug 16, 2018
Enrollment StartAug 18, 2021
Primary CompletionOct 5, 2022
Study CompletionNov 9, 2022
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 7.9 years ago

Interventions

hydroxyurea (20mg/kg/day)drug

Treatment of severe malnutrition in children with SCA in northern Nigeria

Ready-to-use therapeutic fooddietary

Treatment of severe malnutrition in children with and without SCA in northern Nigeria with an additional 500-1000 calories from ready-to-use-therapeutic food