# Management of severe acute malnutrition in children with sickle cell disease greater than 5 years of age living in northern Nigeria

> **NIH NIH R21** · VANDERBILT UNIVERSITY MEDICAL CENTER · 2020 · $219,313

## Abstract

The overall goal of this feasibility trial is to determine the acceptability of a randomized controlled trial to ascertain
the optimal strategy for the treatment of severe malnutrition in children with sickle cell disease (SCD) older than 5
years of age. No international standard or evidence-based guidelines exist for the treatment of severe
malnutrition (defined as BMI Z-score below –3) in children with SCD. With an expanding pediatric population of
more than 75 million in Nigeria, coupled with decreasing childhood infectious disease-related mortality, the next
emerging threats to preventable childhood deaths are non-communicable diseases. Data from our ongoing NIH-
funded randomized controlled primary stroke prevention trial in Nigeria (NCT02560935), in which we evaluated
children with SCD between 5 and 12 years of age, demonstrated that 29% (230/803) of the cohort met criteria
for severe malnutrition. Approximately 92% of the cohort in northern Nigeria identified as having severe
malnutrition was below the 5th percentile for weight of children with SCD living in the US, Canada, or Europe.
These data indicate older children with SCD living in northern Nigeria are undernourished when compared to
children living with SCD in high-resource settings. A potentially unique attribute to treating malnutrition in
children with SCD is the use of FDA approved anti-metabolite, hydroxyurea, to prevent vaso-occlusive pain
events in children. The beneficial effects of hydroxyurea include, but are not limited to, decreased inflammation
and increased hemoglobin levels. Preliminary evidence in our cohort of older children with sickle cell anemia
(SCA) in northern Nigeria reveals that moderate fixed dose hydroxyurea (20 mg/kg/day) significantly increases
BMI in children with severe malnutrition. We propose a randomized controlled feasibility trial in older children (5
to 12 years of age) with SCA living in northern Nigeria. In preparation for a definitive phase III trial to determine
if a nutritional supplement (SoyaPlus) and moderate fixed dose hydroxyurea therapy is superior to a nutritional
supplement alone, we will randomly allocate 100 children between 5 and 12 years of age with SCA and severe
uncomplicated malnutrition to each of the two arms. In aim 1, we will assess the feasibility (rate of recruitment,
retention, and adherence) randomized controlled trial to a 12-week intervention period. We will assess the
feasibility of a RCT in children with SCA and severe malnutrition. For aim 2, we will establish the safety
protocol to monitor for unknown rates of complications associated with treating malnutrition in children with
SCD. To decrease the likelihood of sharing limited food resources in a poor family and to determine the
specificity of malnutrition for children with SCD in northern Nigeria, we will screen and treat up to 100
malnourished non-SCD siblings of the trial participants. After completion of this feasibility trial, we will use the
acquired knowl...

## Key facts

- **NIH application ID:** 9969189
- **Project number:** 5R21HD097992-02
- **Recipient organization:** VANDERBILT UNIVERSITY MEDICAL CENTER
- **Principal Investigator:** SHEHU UMAR ABDULLAHI
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $219,313
- **Award type:** 5
- **Project period:** 2019-09-01 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9969189

## Citation

> US National Institutes of Health, RePORTER application 9969189, Management of severe acute malnutrition in children with sickle cell disease greater than 5 years of age living in northern Nigeria (5R21HD097992-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9969189. Licensed CC0.

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