Management of Severe Acute Malnutrition in SCD, in Northern Nigeria

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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 nutritional feasibility trial is to identify whether families of children with sickle cell anemia (SCA) > 5 years of age 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 of age with and without SCA, in a low-resource setting.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vanderbilt University Medical Center
• Collaborators: Aminu Kano Teaching Hospital; Murtala Muhammad Specialist Hospital; Murtala Muhammad Specialist Hospital, Nigeria
• Treatments: Hydroxyurea

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:

• complicated malnutrition (poor appetite, altered mental status, severe bilateral edema, infections, dehydration, sepsis or respiratory distress)

• unable to swallow