Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT06397118
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-09
First Post:
2024-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevention of Malnutrition in Children With Sickle Cell Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}, {'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'A trained anthropometrist will be masked to the study allocation.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 148}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2024-04-29', 'studyFirstSubmitQcDate': '2024-04-29', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in weight-for-length z-score', 'timeFrame': '24 weeks', 'description': '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.'}, {'measure': 'Change in length-for-age z-score', 'timeFrame': '24 weeks', 'description': '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.'}, {'measure': 'Change in mid-upper arm circumference measurement', 'timeFrame': '24 weeks', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'Change in weight for the for-age z score.', 'timeFrame': '24 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Percentage of children receiving the minimum dietary adequacy', 'timeFrame': '24 weeks', 'description': 'percentage of young children with a World Health Organization-defined minimum acceptable diet based on dietary diversity and feeding frequency'}, {'measure': 'Prevalence of vitamin A deficiency', 'timeFrame': '24 weeks', 'description': 'Continuous unadjusted and inflammation-adjusted retinol levels and the corresponding prevalence of vitamin A deficiency'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Malnutrition', 'Malnourishment', 'Undernutrition', 'Nutritional Deficiency', 'Sickle Cell Disease', 'Nigeria', 'Primary Prevention', 'Vitamin A', 'Infant and Young Child Feeding'], 'conditions': ['Sickle Cell Disease', 'Malnutrition']}, 'referencesModule': {'references': [{'pmid': '30574296', 'type': 'BACKGROUND', '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.'}, {'pmid': '37331373', 'type': 'BACKGROUND', '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.'}, {'type': 'BACKGROUND', 'citation': 'World Health Organization (WHO). Malnutrition Fact Sheets. Published 2021. Accessed June 4, 2022. https://www.who.int/news-room/fact-sheets/detail/malnutrition'}, {'type': 'BACKGROUND', 'citation': 'National Population Commission (NPC) [Nigeria], ICF. Nigeria Demographic and Health Survey 2018.; 2019. Accessed June 26, 2021. www.DHSprogram.com.'}, {'type': 'BACKGROUND', 'citation': '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'}, {'pmid': '26275329', 'type': 'BACKGROUND', 'citation': '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': '28282701', 'type': 'BACKGROUND', '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.'}, {'pmid': '34486229', 'type': 'BACKGROUND', '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.'}, {'pmid': '18207566', 'type': 'BACKGROUND', '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.'}, {'pmid': '36383708', 'type': 'BACKGROUND', '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.'}, {'pmid': '33805040', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '18 Months', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* laboratory confirmed SCD (HbSS, HbSβ0 thalassemia, or HbSC)\n* aged 6 to 18 months.\n\nExclusion Criteria:\n\n* severe acute malnutrition (weight-for-length z-score \\<-3 or mid-upper arm circumference \\<11.5 cm)\n* diagnosis of HIV or other chronic illnesses'}, 'identificationModule': {'nctId': 'NCT06397118', 'acronym': 'PMC-SCD', 'briefTitle': 'Prevention of Malnutrition in Children With Sickle Cell Disease', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Prevention of Malnutrition in Children With Sickle Cell Disease Living in Northern Nigeria', 'orgStudyIdInfo': {'id': '240090'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard Care plus Maternal Nutrition Education', 'description': '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:\n\n1. appropriate feeding frequency\n2. dietary diversity using local foods\n3. Complementary food preparation\n4. adequate portions\n5. individualized, tailored economic education regarding the cost of purchasing foods that can fill nutrient gaps (self-efficacy)', 'interventionNames': ['Behavioral: Maternal Nutrition Education', 'Behavioral: Standard Care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Care Only', 'description': '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.', 'interventionNames': ['Behavioral: Standard Care']}], 'interventions': [{'name': 'Maternal Nutrition Education', 'type': 'BEHAVIORAL', 'description': 'Community Health Worker delivered Maternal Nutrition Education', 'armGroupLabels': ['Standard Care plus Maternal Nutrition Education']}, {'name': 'Standard Care', 'type': 'BEHAVIORAL', 'description': 'Standard care in the sickle cell disease (SCD) clinic', 'armGroupLabels': ['Standard Care Only', 'Standard Care plus Maternal Nutrition Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Lauren J Klein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aminu Kano Teaching Hospital', 'class': 'OTHER'}, {'name': 'Murtala Muhammed Specialist Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Instructor of Pediatric Gastroenterology, Hepatology, and Nutrition', 'investigatorFullName': 'Lauren Klein', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}