Clinical trial NCT06397118: Prevention of Malnutrition in Children with Sickle Cell Disease
Official title: Prevention of Malnutrition in Children with Sickle Cell Disease Living in Northern Nigeria
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Sickle Cell Disease
Malnutrition
Keywords: Malnutrition
Malnourishment
Undernutrition
Nutritional Deficiency
Sickle Cell Disease
Nigeria
Primary Prevention
Vitamin A
Infant and Young Child Feeding
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Aminu Kano Teaching Hospital
name: Murtala Muhammed Specialist Hospital
First posted: 2024-05-02
Enrollment: 148
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible participants will be randomly allocated to intervention or control groups in a 1:1 ratio via a permuted block allocation scheme stratified by sex.
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* laboratory confirmed SCD (HbSS, HbSβ0 thalassemia, or HbSC)
* aged 6 to 18 months.

Exclusion Criteria:

* severe acute malnutrition (weight-for-length z-score \<-3 or mid-upper arm circumference \<11.5 cm)
* diagnosis of HIV or other chronic illnesses

Primary outcomes:
measure: Change in weight for the for-age z score.
timeFrame: 24 weeks
Secondary outcomes:
measure: Percentage of children receiving the minimum dietary adequacy
timeFrame: 24 weeks
measure: Prevalence of vitamin A deficiency
timeFrame: 24 weeks
Other outcomes:
measure: Change in weight-for-length z-score
timeFrame: 24 weeks
measure: Change in length-for-age z-score
timeFrame: 24 weeks
measure: Change in mid-upper arm circumference measurement
timeFrame: 24 weeks
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Lauren J Klein, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: World Health Organization (WHO). Malnutrition Fact Sheets. Published 2021. Accessed June 4, 2022. https://www.who.int/news-room/fact-sheets/detail/malnutrition
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