Management of Severe Acute Malnutrition in SCD, in Northern Nigeria
Completed · Phase 2
Conditions studied: Sickle Cell Anemia, Severe Acute Malnutrition
In brief
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.
Key facts
- Study ID
- NCT03634488
- Run by
- Vanderbilt University Medical Center
- People needed
- 132
- Starts
- 2021-08-18
- Expected to finish
- 2022-11-09
- Last updated by the study team
- 2024-03-27
Who can join
Age: 5 and older, up to 12. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- confirmed diagnoses of SCA, comparison children without SCD
- severe malnutrition defined as a BMI z-score < -3
- age between 5 and 12 years (assessment can take place up until the 13th birthday)
- pass the appetite test
- uncomplicated malnutrition (good appetite, alert, no signs of infection of respiratory distress)
You may not qualify if…
- children with complicated severe acute malnutrition
- children with electrolyte disturbances (serum Na, K, PO4) at baseline
- children on disease-modifying therapy (hydroxyurea or regular blood transfusion therapy)
- children enrolled in other studies
- children with diabetes and other chronic illnesses
- children with known HIV infection
- children with a known allergy to dairy or peanuts.
Where it is running
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
- Aminu Kano Teaching Hospital — Kano, Nigeria
- Murtala Mohammad Specialist Hospital — Kano, Nigeria
Full record on ClinicalTrials.gov
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