Prevention of Malnutrition in Children With Sickle Cell Disease

Sickle Cell Disease Clinical Trial

— PMC-SCD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06397118
• Other study ID #: 240090
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: May 31, 2027

Study information

• Verified date: May 2024
• Source: Vanderbilt University Medical Center
• Contact: Tiffany Bess, MA
• Phone: 314-322-7791
• Email: tiffany.bess[@]vumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 148
• Est. completion date: May 31, 2027
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Months

Eligibility

Inclusion Criteria:

• laboratory confirmed SCD (HbSS, HbSß0 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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Child Nutrition Disorders
• Malnutrition
• Sickle Cell Disease

Intervention

Behavioral:
• Maternal Nutrition Education
Community Health Worker delivered Maternal Nutrition Education
• Standard Care
Standard care in the sickle cell disease (SCD) clinic

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Aminu Kano Teaching Hospital, Murtala Muhammed Specialist Hospital

References & Publications (11)

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. — View Citation

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. — View Citation

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. Erratum In: Lancet Haematol. 2023 Aug;10(8):e574. — View Citation

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. — View Citation

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. — View Citation

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

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

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. — View Citation

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. — View Citation

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. — View Citation

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

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in weight-for-length z-score	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
Other	Change in length-for-age z-score	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
Other	Change in mid-upper arm circumference measurement	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
Primary	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	Percentage of children receiving the minimum dietary adequacy	percentage of young children with a World Health Organization-defined minimum acceptable diet based on dietary diversity and feeding frequency	24 weeks
Secondary	Prevalence of vitamin A deficiency	Continuous unadjusted and inflammation-adjusted retinol levels and the corresponding prevalence of vitamin A deficiency	24 weeks