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Management of Severe Acute Malnutrition in SCD, in Northern Nigeria

NCT03634488 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2024-03-27

Study results available
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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.

Conditions

Interventions

DRUG

hydroxyurea (20mg/kg/day)

Treatment of severe malnutrition in children with SCA in northern Nigeria

DIETARY_SUPPLEMENT

Ready-to-use therapeutic food

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

Sponsors & Collaborators

  • Aminu Kano Teaching Hospital

    collaborator OTHER

  • Murtala Muhammad Specialist Hospital

    collaborator OTHER

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Michael DeBaun · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-18
Primary Completion
2022-10-05
Completion
2022-11-09
FDA Drug
Yes

Countries

  • United States
  • Nigeria

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03634488 on ClinicalTrials.gov