Management of Severe Acute Malnutrition in SCD, in Northern Nigeria



Status:Not yet recruiting
Conditions:Food Studies, Anemia
Therapuetic Areas:Hematology, Pharmacology / Toxicology
Healthy:No
Age Range:5 - 12
Updated:1/26/2019
Start Date:October 2019
End Date:February 2022
Contact:Michael DeBaun, MD, MPH
Email:m.debaun@vanderbilt.edu
Phone:615-875-3040

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Management of Severe Acute Malnutrition in Children With Sickle Cell Disease Greater Than 5 Years of Age Living in Northern Nigeria

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.

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 the investigators 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 this 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.
The investigators 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, the investigators 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, the investigators will assess
the feasibility (rate of recruitment, retention, and adherence) of a randomized controlled
trial (RCT) in children with SCA and severe malnutrition to a 12-week intervention period.
For aim 2, the investigators 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, the investigators will
screen and treat up to 100 malnourished non-SCD siblings of the trial participants. After
completion of this feasibility trial, the investigators will use the acquired knowledge to
design a phase III trial to definitively determine the optimal treatment strategy for severe
malnutrition in older children with SCD living in Africa, potentially affecting thousands of
children in this region.

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
We found this trial at
2
sites
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Phone: 615-875-3040
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Kano,
Principal Investigator: Najibah Galadanchi, MBBS,FMCPath
Phone: 234-803-700-5452
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Kano,
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