Adults 5 to 12, any sex, with Sickle Cell Anemia or Severe Acute Malnutrition. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Enrollment Rate at the End of the 6-month Recruitment PeriodPrimary· 6 months
Recruitment Feasibility: The primary outcome is the proportion of eligible individuals that agree to be included, referred to as the recruitment rate. Children with severe malnutrition who qualified and agreed to participate were invited to sign a consent and assent for study recruitment to this study.
Eligible
Group
Value
95% CI
Eligible Children Aged 5-12 Years With SCA
111
Eligible Children Aged 5-12 Years Old Without SCD
22
Randomized
Group
Value
95% CI
Eligible Children Aged 5-12 Years With SCA
110
Eligible Children Aged 5-12 Years Old Without SCD
22
Unable to randomize
Group
Value
95% CI
Eligible Children Aged 5-12 Years With SCA
1
Eligible Children Aged 5-12 Years Old Without SCD
0
Retention Over 12-week PeriodPrimary· 12 weeks
The primary outcome is the proportion of participants who completed the 12-week trial, known as the retention rate for the trial.
Voluntarily withdrew from the trial
Group
Value
95% CI
SCD - Ready-to-use Therapeutic Food and Hydroxyurea
0
SCD - Ready-to-use Therapeutic Food Alone
0
Siblings Without SCD
0
Involuntary withdrawal from the trial
Group
Value
95% CI
SCD - Ready-to-use Therapeutic Food and Hydroxyurea
1
SCD - Ready-to-use Therapeutic Food Alone
0
Siblings Without SCD
0
Percentage of Ready-to-use Therapeutic Food Sachets Returned as Empty.Primary· 12 weeks
Adherence to the ready-to-use therapeutic food was evaluated based on the percentage of empty food sachets returned at each visit.
Group
Value
95% CI
SCD - Ready-to-use Therapeutic Food and Hydroxyurea
99.02
99.00 – 99.04
SCD - Ready-to-use Therapeutic Food Alone
99.03
99.0 – 99.05
Siblings Without SCD
99.02
99.01 – 99.04
Number of Missed VisitsPrimary· 12 weeks
Adherence to monthly visits was assessed based on the number of missed visits
Group
Value
95% CI
SCD - Ready-to-use Therapeutic Food and Hydroxyurea
0
SCD - Ready-to-use Therapeutic Food Alone
0
Siblings Without SCD
0
Percentage of Hydroxyurea Pills ReturnedPrimary· 12 weeks
Adherence to hydroxyurea was evaluated based on the percentage of hydroxyurea pills returned for the group randomized to both ready-to-use therapeutic food and hydroxyurea.
Group
Value
95% CI
SCD - Ready-to-use Therapeutic Food and Hydroxyurea
4.4
0.00 – 8.27
Change in Mean Corpuscular VolumePrimary· 12 weeks
Adherence to hydroxyurea was evaluated based on change in mean corpuscular volume
Group
Value
95% CI
Ready-to-use Therapeutic Food and Hydroxyurea
5.4
± 12.7
Ready-to-use Therapeutic Food Alone
-1.0
± 10.9
Change in Fetal Hemoglobin Level PercentagePrimary· Baseline to 12 weeks
The primary outcome is the proportion of eligible individuals who adhere to therapy (Ready-to-use therapeutic food and hydroxyurea). The adherence rate for hydroxyurea was determined based on the change in fetal hemoglobin level percentage.
Group
Value
95% CI
SCD - Ready-to-use Therapeutic Food and Hydroxyurea
3.9
1.7 – 6.8
Ready-to-use Therapeutic Food Alone
2.2
0.5 – 4.9
Mean Corpuscular Volume Values at ExitPrimary· Feasibility over 12-week Period [Time Frame: 3 months]
The primary outcome is the proportion of eligible individuals who adhere to therapy (Ready-to-use therapeutic food and hydroxyurea). The adherence rate for hydroxyurea was determined based on mean corpuscular volume (MCV) values at exit (12 weeks).
Group
Value
95% CI
Ready-to-use Therapeutic Food and Hydroxyurea
88.5
± 14.7
Ready-to-use Therapeutic Food Alone
85.4
± 11.4
Fetal Hemoglobin Levels at ExitPrimary· Feasibility over 12-week Period [Time Frame: 3 months]
The primary outcome is the proportion of eligible individuals who adhere to therapy (Ready-to-use therapeutic food and hydroxyurea). The adherence rate for hydroxyurea was determined based on the fetal hemoglobin levels at exit (12 weeks).
Group
Value
95% CI
Ready-to-use Therapeutic Food and Hydroxyurea
12.2
7.5 – 16.9
Ready-to-use Therapeutic Food Alone
9.4
5.6 – 13.8
Total Hemoglobin Levels at ExitPrimary· Feasibility over 12-week Period [Time Frame: 3 months]
The primary outcome is the proportion of eligible individuals who adhere to therapy (Ready-to-use therapeutic food and hydroxyurea). The adherence rate for hydroxyurea was determined based on the total hemoglobin levels at exit (12 weeks).
Group
Value
95% CI
Ready-to-use Therapeutic Food and Hydroxyurea
8.3
± 1.1
Ready-to-use Therapeutic Food Alone
7.7
± 1.3
Percentage of Participants Maintaining a BMI Z-score Less Than -3.0Secondary· 12 weeks
As a secondary outcome, we assessed the percentage of participants with and without SCA who continued to have a body mass index z-score of \<-3.0 at the end of the 12 weeks of treatment. Using the World Health Organization (WHO) growth reference, anthropometric measurements were converted to age and sex-specific z-scores. Anthropometric Indices (BMI-for-age (BMIZ), were calculated using WHO 2007 R Macro Package to assess growth and development of the children. Severe malnutrition/wasting (SAM) was defined as a body mass index (BMI) z-score \<-3.0.
Group
Value
95% CI
Ready-to-use Therapeutic Food and Hydroxyurea
66.7
Ready-to-use Therapeutic Food Alone
55.6
Siblings Without SCD
30.1
Adverse events — posted to ClinicalTrials.gov
Time frame: The adverse event data was collected during the participant's 12-week study period, about 7 months after enrollment..
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Vanderbilt University Medical Center
Last refreshed: 27 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03634488.