Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06397118
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-04-29
Brief Title:
Prevention of Malnutrition in Children With Sickle Cell Disease
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
Prevention of Malnutrition in Children With Sickle Cell Disease Living in Northern Nigeria
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PMC-SCD
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None