Trials / Active Not Recruiting
Active Not RecruitingNCT06397118
Prevention of Malnutrition in Children With Sickle Cell Disease
Prevention of Malnutrition in Children With Sickle Cell Disease Living in Northern Nigeria
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 148 (estimated)
- Sponsor
- Vanderbilt University Medical Center · Academic / Other
- Sex
- All
- Age
- 6 Months – 18 Months
- Healthy volunteers
- Not accepted
Summary
The investigators are studying how to prevent malnutrition in children with sickle cell disease (SCD) in northern Nigeria. Community health workers will teach mothers about nutritious local foods that might help children grow better than the usual advice from doctors. The investigators will enroll 148 children with SCD aged 6 to 18 months old. The investigators will determine if their weight and diet improve and check for low vitamin A levels. This information will help us find better ways to improve growth for children with SCD.
Detailed description
Despite efforts to improve nutrition, 45% of under-5 mortality is at least partially attributable to malnutrition. Children with SCD have high nutrient demands and energy expenditures with a risk of impaired growth. The investigators will test the hypothesis that maternal nutrition education on locally available nutrient-dense foods will lead to improved childhood growth compared to standard pediatrician-delivered nutrition counseling. The research will involve a randomized controlled trial with 148 children aged 6 to 18 months with SCD, assessing changes in weight-for-age z-scores and dietary adequacy, as well as determining the prevalence of vitamin A deficiency. These preliminary findings will inform evidence-based interventions for the primary prevention of malnutrition (underweight and vitamin A deficiency) in children with SCD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Maternal Nutrition Education | Community Health Worker delivered Maternal Nutrition Education |
| BEHAVIORAL | Standard Care | Standard care in the sickle cell disease (SCD) clinic |
Timeline
- Start date
- 2024-11-06
- Primary completion
- 2026-05-01
- Completion
- 2027-05-31
- First posted
- 2024-05-02
- Last updated
- 2025-12-09
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT06397118. Inclusion in this directory is not an endorsement.