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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

TypeNameDescription
BEHAVIORALMaternal Nutrition EducationCommunity Health Worker delivered Maternal Nutrition Education
BEHAVIORALStandard CareStandard 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.