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NCT03634488 · ClinicalTrials.gov registry record · Phase 2
Management of Severe Acute Malnutrition in SCD, in Northern Nigeria
A Phase 2 study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 132
- Enrollment target
NCT03634488: Completed Phase 2 study, sponsored by Vanderbilt University Medical Center.
NCT03634488 is a Phase 2 study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 132 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03634488, a Phase 2 study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 132 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG hydroxyurea (20mg/kg/day)
- DIETARY_SUPPLEMENT Ready-to-use therapeutic food
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2021-08-18 |
| Est. Completion | 2022-11-09 |
| Phase | Phase 2 |
What the finished NCT03634488 record still lists
NCT03634488 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which hydroxyurea (20mg/kg/day) is the first listed.
NCT03634488 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03634488 about?
NCT03634488 is a clinical study titled "Management of Severe Acute Malnutrition in SCD, 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 nutrition feasibility trial is to identify whether families of children with sickle cell disease (SCD) 5 years and older agree ...
What is the current status of trial NCT03634488?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 132 participants. The study started on 2021-08-18. Estimated completion is 2022-11-09.
What interventions are being tested in trial NCT03634488?
The interventions under investigation include: hydroxyurea (20mg/kg/day) (DRUG), Ready-to-use therapeutic food (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03634488?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03634488's enrollment target sits among peer trials
132 539th of 2000 higher than 1,460 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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