Malnutrition, Sickle Cell Disease
Conditions
Keywords
Malnutrition, Malnourishment, Undernutrition, Nutritional Deficiency, Sickle Cell Disease, Nigeria, Primary Prevention, Vitamin A, Infant and Young Child Feeding
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.
Interventions
BEHAVIORALMaternal Nutrition Education
Community Health Worker delivered Maternal Nutrition Education
BEHAVIORALStandard Care
Standard care in the sickle cell disease (SCD) clinic
Sponsors
Vanderbilt University Medical Center
Aminu Kano Teaching Hospital
Murtala Muhammed Specialist Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
A trained anthropometrist will be masked to the study allocation.
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.
Eligibility
Sex/Gender
ALL
Age
6 Months to 18 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in weight for the for-age z score. | 24 weeks | Mean change in weight-for-age z score in the randomly allocated groups, standard care versus the novel maternal intervention. This is a continuous outcome where a higher z-score indicates a positive outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of children receiving the minimum dietary adequacy | 24 weeks | percentage of young children with a World Health Organization-defined minimum acceptable diet based on dietary diversity and feeding frequency |
| Prevalence of vitamin A deficiency | 24 weeks | Continuous unadjusted and inflammation-adjusted retinol levels and the corresponding prevalence of vitamin A deficiency |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLauren J Klein, MD
Vanderbilt University Medical Center
Outcome results
None listed