Prevention of Malnutrition in Children With Sickle Cell Disease (PMC-SCD)

December 2, 2025 updated by: Lauren Klein, Vanderbilt University Medical Center

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

148

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standard Care plus Maternal Nutrition Education

Mothers whose infants are assigned to this group will be provided individually by a community health worker during weeks 0, 8, and 16. In addition to receiving nutrition counseling, maternal nutrition education will emphasize utilizing locally available foods to enhance the nutritional well-being of young children and families, all while respecting local cultural and religious customs. To reinforce these educational messages, visual aids will be incorporated. The following educational messages will be addressed:

  1. appropriate feeding frequency
  2. dietary diversity using local foods
  3. Complementary food preparation
  4. adequate portions
  5. individualized, tailored economic education regarding the cost of purchasing foods that can fill nutrient gaps (self-efficacy)
Behavioral: Maternal Nutrition Education
Community Health Worker delivered Maternal Nutrition Education
Behavioral: Standard Care
Standard care in the sickle cell disease (SCD) clinic
Active Comparator: Standard Care Only
Mothers whose infants are assigned to the control group will receive standard nutrition education from the provider at the SCD clinic during weeks 0, 8, and 16.
Behavioral: Standard Care
Standard care in the sickle cell disease (SCD) clinic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 weeks
Prevalence of vitamin A deficiency
Time Frame: 24 weeks
Continuous unadjusted and inflammation-adjusted retinol levels and the corresponding prevalence of vitamin A deficiency
24 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 weeks
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.
24 weeks
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.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Collaborators

Aminu Kano Teaching Hospital
Murtala Muhammed Specialist Hospital

Investigators

  • Principal Investigator: Lauren J Klein, MD, Vanderbilt University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

April 29, 2024

First Submitted That Met QC Criteria

April 29, 2024

First Posted (Actual)

May 2, 2024

Study Record Updates

Last Update Posted (Estimated)

December 9, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 240090

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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