Prevention of Malnutrition in Children With Sickle Cell Disease

NCT06397118 | Active Not Recruiting

• 1 other identifier: 240090
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition; Sickle Cell Disease

Keywords

Malnutrition; Malnourishment; Undernutrition; Nutritional Deficiency; Sickle Cell Disease; Nigeria; Primary Prevention; Vitamin A; Infant and Young Child Feeding

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (2)

• Percentage of children receiving the minimum dietary adequacy

  24 weeks

• Prevalence of vitamin A deficiency

  24 weeks

Other Outcomes (3)

• Change in weight-for-length z-score

  24 weeks

• Change in length-for-age z-score

  24 weeks

• Change in mid-upper arm circumference measurement

  24 weeks

Study Arms (2)

Standard Care plus Maternal Nutrition Education

EXPERIMENTAL

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; Behavioral: Standard Care

Standard Care Only

ACTIVE COMPARATOR

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

Interventions

Standard Care BEHAVIORAL

Standard care in the sickle cell disease (SCD) clinic

Standard Care Only; Standard Care plus Maternal Nutrition Education

Maternal Nutrition Education BEHAVIORAL

Community Health Worker delivered Maternal Nutrition Education

Standard Care plus Maternal Nutrition Education

Eligibility Criteria

• Age: 6 Months - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aminu Kano Teaching Hospital: collaborator
• Murtala Muhammed Specialist Hospital: collaborator
• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

Related Publications (11)

• Wastnedge E, Waters D, Patel S, Morrison K, Goh MY, Adeloye D, Rudan I. The global burden of sickle cell disease in children under five years of age: a systematic review and meta-analysis. J Glob Health. 2018 Dec;8(2):021103. doi: 10.7189/jogh.08.021103.

  PMID: 30574296 BACKGROUND

• GBD 2021 Sickle Cell Disease Collaborators. Global, regional, and national prevalence and mortality burden of sickle cell disease, 2000-2021: a systematic analysis from the Global Burden of Disease Study 2021. Lancet Haematol. 2023 Aug;10(8):e585-e599. doi: 10.1016/S2352-3026(23)00118-7. Epub 2023 Jun 15.

  PMID: 37331373 BACKGROUND

• World Health Organization (WHO). Malnutrition Fact Sheets. Published 2021. Accessed June 4, 2022. https://www.who.int/news-room/fact-sheets/detail/malnutrition

  BACKGROUND

• National Population Commission (NPC) [Nigeria], ICF. Nigeria Demographic and Health Survey 2018.; 2019. Accessed June 26, 2021. www.DHSprogram.com.

  BACKGROUND

• Park H, Schall J, Zemel B, et al. Parameters of vitamin A (VA) status in children with sickle cell disease (SCD). The FASEB Journal. 2009;23(S1):730.5-730.5. doi:10.1096/fasebj.23.1 supplement.730.5

  BACKGROUND

• Stevens GA, Bennett JE, Hennocq Q, Lu Y, De-Regil LM, Rogers L, Danaei G, Li G, White RA, Flaxman SR, Oehrle SP, Finucane MM, Guerrero R, Bhutta ZA, Then-Paulino A, Fawzi W, Black RE, Ezzati M. Trends and mortality effects of vitamin A deficiency in children in 138 low-income and middle-income countries between 1991 and 2013: a pooled analysis of population-based surveys. Lancet Glob Health. 2015 Sep;3(9):e528-36. doi: 10.1016/S2214-109X(15)00039-X.

  PMID: 26275329 BACKGROUND

• Imdad A, Mayo-Wilson E, Herzer K, Bhutta ZA. Vitamin A supplementation for preventing morbidity and mortality in children from six months to five years of age. Cochrane Database Syst Rev. 2017 Mar 11;3(3):CD008524. doi: 10.1002/14651858.CD008524.pub3.

  PMID: 28282701 BACKGROUND

• Thurstans S, Sessions N, Dolan C, Sadler K, Cichon B, Isanaka S, Roberfroid D, Stobaugh H, Webb P, Khara T. The relationship between wasting and stunting in young children: A systematic review. Matern Child Nutr. 2022 Jan;18(1):e13246. doi: 10.1111/mcn.13246. Epub 2021 Sep 5.

  PMID: 34486229 BACKGROUND

• Black RE, Allen LH, Bhutta ZA, Caulfield LE, de Onis M, Ezzati M, Mathers C, Rivera J; Maternal and Child Undernutrition Study Group. Maternal and child undernutrition: global and regional exposures and health consequences. Lancet. 2008 Jan 19;371(9608):243-60. doi: 10.1016/S0140-6736(07)61690-0. No abstract available.

  PMID: 18207566 BACKGROUND

• Klein LJ, Abdullahi SU, Gambo S, Stallings VA, Acra S, Rodeghier M, DeBaun MR. Underweight children older than 5 years with sickle cell anemia are at risk for early mortality in a low-resource setting. Blood Adv. 2023 Jun 13;7(11):2339-2346. doi: 10.1182/bloodadvances.2022008623.

  PMID: 36383708 BACKGROUND

• Bailey J, Lelijveld N, Khara T, Dolan C, Stobaugh H, Sadler K, Lino Lako R, Briend A, Opondo C, Kerac M, Myatt M. Response to Malnutrition Treatment in Low Weight-for-Age Children: Secondary Analyses of Children 6-59 Months in the ComPAS Cluster Randomized Controlled Trial. Nutrients. 2021 Mar 24;13(4):1054. doi: 10.3390/nu13041054.

  PMID: 33805040 BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell; Malnutrition

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Lauren J Klein, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A trained anthropometrist will be masked to the study allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Pediatric Gastroenterology, Hepatology, and Nutrition

Model Details: 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.

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 2, 2024
• Study Start: November 6, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)