Phase 2
N=132
Management of Severe Acute Malnutrition in SCD, in Northern Nigeria
Sickle Cell Anemia · Severe Acute Malnutrition
Bottom Line
View on ClinicalTrials.gov: NCT03634488 ↗Enrolled (actual)
132
Serious AEs
0.8%
Results posted
Mar 2024
Primary outcome: Primary: Enrollment Rate at the End of the 6-month Recruitment Period — 111; 22; 110; 22 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- hydroxyurea (20mg/kg/day) (Drug); Ready-to-use therapeutic food (Dietary_supplement)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Enrollment Rate at the End of the 6-month Recruitment Period |
111; 22; 110; 22; 1; 0 | — |
| PRIMARY Retention Over 12-week Period |
0; 0; 0; 1; 0; 0 | — |
| PRIMARY Percentage of Ready-to-use Therapeutic Food Sachets Returned as Empty. |
99.02; 99.03; 99.02 | — |
| PRIMARY Number of Missed Visits |
0; 0; 0 | — |
| PRIMARY Percentage of Hydroxyurea Pills Returned |
4.4 | — |
| PRIMARY Change in Mean Corpuscular Volume |
5.4; -1.0 | — |
| PRIMARY Change in Fetal Hemoglobin Level Percentage |
3.9; 2.2 | — |
| PRIMARY Mean Corpuscular Volume Values at Exit |
88.5; 85.4 | — |
| PRIMARY Fetal Hemoglobin Levels at Exit |
12.2; 9.4 | — |
| PRIMARY Total Hemoglobin Levels at Exit |
8.3; 7.7 | — |
| SECONDARY Percentage of Participants Maintaining a BMI Z-score Less Than -3.0 |
66.7; 55.6; 30.1 | — |
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.
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, 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.
Data sourced from ClinicalTrials.gov (NCT03634488). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.