Management of Severe Acute Malnutrition in SCD, in Northern Nigeria
Sickle Cell Anemia, Severe Acute Malnutrition
About this trial
This is an interventional treatment trial for Sickle Cell Anemia focused on measuring sickle cell disease, sub-Saharan Africa, malnutrition, low-income settings, severe acute malnutrition, sickle cell anemia, Nigeria
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- children with complicated severe acute malnutrition
- children with electrolyte disturbances (serum Na, K, Ca, 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.
Sites / Locations
- Vanderbilt University Medical Center
- Aminu Kano Teaching Hospital
- Murtala Mohammad Specialist Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Placebo Comparator
Placebo Comparator
Ready-to-use therapeutic food and Hydroxyurea
Ready-to-use therapeutic food alone
non-SCD AND severe malnutrition
50 children (5-12 years old) with SCA and severe malnutrition will be randomly allocated to receive Ready-to-use therapeutic food and hydroxyurea (20mg/kg/day)
50 children (5-12 years old) with SCA and severe malnutrition will be randomly allocated to receive Ready-to-use therapeutic food alone
To decrease the likelihood of sharing limited food resources, we will enroll up to 100 malnourished non-SCD siblings.