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Completed

NCT Number: NCT06397118

Prevention of Malnutrition in Children With Sickle Cell Disease

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.

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

6 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Maternal Nutrition Education

Behavioral

Community Health Worker delivered Maternal Nutrition Education

Standard Care

Behavioral

Standard care in the sickle cell disease (SCD) clinic

Primary outcomes

  1. Change in weight for the for-age z score.

    Time frame: 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 outcomes

  1. Percentage of children receiving the minimum dietary adequacy

    Time frame: 24 weeks

    percentage of young children with a World Health Organization-defined minimum acceptable diet based on dietary diversity and feeding frequency

  2. Prevalence of vitamin A deficiency

    Time frame: 24 weeks

    Continuous unadjusted and inflammation-adjusted retinol levels and the corresponding prevalence of vitamin A deficiency

Other outcomes

  1. Change in weight-for-length z-score

    Time frame: 24 weeks

    Mean change in weight-for-length 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.

  2. Change in length-for-age z-score

    Time frame: 24 weeks

    Mean change in length-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.

  3. Change in mid-upper arm circumference measurement

    Time frame: 24 weeks

    Mean change in mid-upper arm circumference measurement in the randomly allocated groups, standard care versus the novel maternal intervention. This is a continuous outcome where a mid-upper arm circumference indicates a positive outcome.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • Aminu Kano Teaching Hospital
  • Murtala Muhammed Specialist Hospital

Registry information

Official study title

Prevention of Malnutrition in Children With Sickle Cell Disease Living in Northern Nigeria

Acronym: PMC-SCD

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 2, 2024
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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