Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-02-17 @ 5:03 PM
Study NCT ID:
NCT06912620
Status:
RECRUITING
Last Update Posted:
2025-04-06
First Post:
2025-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alternative RUTFs for Treatment of Child Wasting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067011', 'term': 'Severe Acute Malnutrition'}, {'id': 'D002100', 'term': 'Cachexia'}], 'ancestors': [{'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013851', 'term': 'Thinness'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The products will be provided in identical packaging and the participants, the care providers, the investigators, and outcomes assessors will be blinded to treatment assessment. However, the products may taste different and thus participants may know that they are receiving an alternative RUTF if they are familiar with the standard RUTF product.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2160}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2025-03-19', 'studyFirstSubmitQcDate': '2025-04-02', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anthropometric recovery', 'timeFrame': 'At discharge, which is up to 12 weeks after admission', 'description': 'Weight-for-length z-score (WLZ) ≥ -2 and middle upper arm circumference (MUAC) ≥ 125 mm and absence of bilateral pitting edema for two consecutive visits'}, {'measure': 'Default from treatment', 'timeFrame': 'During treatment, which is up to 12 weeks after admission', 'description': 'Child is absent for two consecutive visits, declared a defaulter on the second visit'}, {'measure': 'Relapse to wasting', 'timeFrame': 'Within 3 months post-discharge', 'description': 'A new episode of wasting (defined as weight-for-length/height z-score \\[WLZ/WHZ\\] \\< -2 or middle upper arm circumference \\[MUAC\\] \\< 125 mm or presence of bilateral pitting edema) within the 3-month period following recovery from the index wasting episode, among children who recovered from their index episode'}, {'measure': 'Transfer to inpatient treatment', 'timeFrame': 'During treatment, which is up to 12 weeks after admission', 'description': 'Referral or admission to hospital for inpatient treatment during the treatment course'}, {'measure': 'Weight gain', 'timeFrame': 'During treatment, which is up to 12 weeks after admission', 'description': "Change in child's weight (gram/kilogram/day) between weight on day of admission to treatment and day of discharge"}, {'measure': 'Non-response to treatment', 'timeFrame': 'During treatment, which is up to 12 weeks after admission', 'description': 'Any of the following criteria are met: Absence of weight gain after 5 weeks or at the third visit; weight loss for more than 4 weeks in the program or at the second visit; loss of more than 5% of body weight compared to admission weight at any time; or anthropometric recovery criteria not met after 3 months of follow-up in treatment'}, {'measure': 'Adherence to treatment services', 'timeFrame': 'During treatment, which is up to 12 weeks after admission', 'description': 'Caregiver attends the recommended schedule of visits and receive ready-to-use therapeutic foods (RUTF) supply'}, {'measure': 'Length of stay', 'timeFrame': 'During treatment, which is up to 12 weeks after admission', 'description': 'The number of days between the day the child is admitted to treatment and the day the child is determined to be recovered and thus discharged from treatment'}, {'measure': 'Anthropometry', 'timeFrame': 'At discharge, which is up to 12 weeks after admission', 'description': 'Weight-for-length/height z-score (WLZ/WHZ), middle upper arm circumference (MUAC), weight, height/length, length/height-for-age z-score (LAZ/HAZ) and weight-for-age z-score (WAZ)'}, {'measure': 'Relapse to MAM', 'timeFrame': 'Within 3 months post-discharge', 'description': 'A new episode of MAM (weight-for-length/height z-score \\[WLZ/WHZ\\] \\<-2 and ≥-3, or middle upper arm circumference \\[MUAC\\] \\<125 mm and ≥115 mm) within the 3-month period following recovery from the index wasting episode'}, {'measure': 'Relapse to SAM', 'timeFrame': 'Within 3 months post-discharge', 'description': 'A new episode of SAM (weight-for-length/height z-score \\[WLZ/WHZ\\] \\< -3 or middle upper arm circumference \\[MUAC\\] \\< 115 mm or presence of bilateral pitting edema) within the 3-month period following recovery from the index wasting episode'}, {'measure': 'Anthropometry', 'timeFrame': 'At 3 months post-discharge', 'description': 'Weight-for-length/height z-score (WLZ/WHZ), middle upper arm circumference (MUAC), weight, height/length, length/height-for-age z-score (LAZ/HAZ) and weight-for-age z-score (WAZ)'}, {'measure': 'Hemoglobin', 'timeFrame': 'At discharge, which is up to 12 weeks after admission', 'description': 'Hemoglobin concentration (grams/liter)'}, {'measure': 'Hemoglobin', 'timeFrame': 'At 3 months post-discharge', 'description': 'Hemoglobin concentration (grams/liter)'}], 'secondaryOutcomes': [{'measure': 'Morbidity', 'timeFrame': 'During treatment, which is up to 12 weeks after admission', 'description': 'Indication of morbidity (acute respiratory infections, diarrhea, fever, or malaria) on health center card'}, {'measure': 'Anemia', 'timeFrame': 'At discharge, which is up to 12 weeks after admission', 'description': 'Hemoglobin concentration \\< 105 gram/liter for children 6-23 months of age Hemoglobin concentration \\< 110 gram/liter for children 24-59 months of age'}, {'measure': 'Anemia', 'timeFrame': 'At 3 months post-discharge', 'description': 'Hemoglobin concentration \\< 110 gram/liter'}, {'measure': 'Mortality', 'timeFrame': 'During treatment, which is up to 12 weeks after admission, or during the 3-month post-discharge follow up', 'description': 'Child has deceased'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Severe Acute Malnutrition', 'Moderate Acute Malnutrition', 'Wasting', 'Ready-to-use Therapeutic Foods', 'RUTFs', 'Wasting relapse', 'Plant-based RUTF', 'Dairy-free RUTF', 'Peanut-free RUTF'], 'conditions': ['Severe Acute Malnutrition', 'Moderate Acute Malnutrition', 'Wasting']}, 'descriptionModule': {'briefSummary': 'Acute malnutrition is the most life-threatening form of undernutrition. Moderate and severe acute malnutrition (MAM, SAM) are effectively treated with ready-to-use therapeutic foods (RUTFs) but there is a need to lower the cost of treatment and improve treatment regimens to reduce risk of relapse MAM/SAM episodes following recovery. The currently used standard formulation of RUTF contains peanuts and dairy, which pose problems due to their high cost, the need to import ingredients to the Global South (in the case of dairy), and risk of aflatoxin (in the case of peanuts). Before alternative formulations of RUTF can be recommended, however, there is the need for data on the efficacy of these formulations on recovery rates and to what extent recovery is sustainable. Sustainable recovery implies a lower rate of post-treatment relapse.\n\nThe study objectives are as follows: (1) To assess the non-inferiority of soy-maize-sorghum (SMS-) RUTF and soy-based (S-) RUTF on treatment recovery to standard RUTF; (2) To assess the superiority of SMS-RUTF and S- RUTF on post-recovery relapse compared to standard RUTF; (3) To assess the costs of a treatment course of SMS-RUTF, S-RUTF, and standard RUTF; (4) To assess the effect of SMS-RUTF and S-RUTF on microbiome composition and intestinal inflammation\n\nThe investigators will conduct a facility-based, individually randomized controlled trial with three arms allocated in a 1:1:1 allocation ratio in 30 health facilities (Centre de Santé et Promotion Sociale \\[CSPS\\]) in Burkina Faso. The investigators will randomize 1080 children with MAM and 1080 children with uncomplicated SAM 6-59 months of age to receive treatment with one of the following RUTFs: (1) standard of care, milk- and peanut-based RUTF (control group); (2) SMS-RUTF free of milk and peanuts and high in fiber (intervention 1); or (3) S-RUTF free of milk and peanuts (intervention 2). Children will be enrolled upon presentation to facilities for MAM or uncomplicated SAM treatment. Follow up visits will be weekly during treatment for SAM children and bi-weekly during treatment for MAM children, and monthly for 3 months following discharge from treatment. The primary study outcomes include, among others, anthropometric recovery at discharge (a non-inferiority analysis) and relapse to MAM or SAM within the 3 months following recovery (a superiority analysis). The investigators will employ an activity-based micro-costing approach to collect cost data on the direct and indirect medical costs, opportunity costs to caregivers, personnel, and overheads associated with outpatient MAM or SAM treatment. Fecal samples will be collected from children at a subset of facilities (5 facilities, \\~60 children per treatment arm), at enrollment (initiation of treatment), discharge from treatment, and 3-months post-discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '59 Months', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 6-59 months\n* MUAC \\< 12.5 cm, or WLZ/WHZ \\< -2\n* Absence of clinical complications or nutritional edema\n* Pass the appetite test\n* Accompanied by caregiver or legal guardian\n* Caregiver or legal guardian consents to participate\n\nExclusion Criteria:\n\n* Acute malnutrition requiring hospitalization (presence of clinical complications, failure to pass the appetite test, or presence of bilateral pitting edema)\n* Known allergy to any of the ingredients in the RUTF products\n* Already enrolled in MAM or SAM treatment program\n* Presence of physical abnormalities that make measurement of anthropometry impossible\n* Caregiver has intention to move out of the study area within the next 6 months\n* Children referred from in-patient facilities to continue in ambulatory care'}, 'identificationModule': {'nctId': 'NCT06912620', 'briefTitle': 'Alternative RUTFs for Treatment of Child Wasting', 'organization': {'class': 'OTHER', 'fullName': 'International Food Policy Research Institute'}, 'officialTitle': 'Efficacy of Alternative RUTFs for Treatment of Child Wasting and Prevention of Relapse', 'orgStudyIdInfo': {'id': '2024-RUTF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard RUTF', 'description': 'This is the control arm of the trial, in which children will receive the standard RUTF product for treatment of acute malnutrition', 'interventionNames': ['Dietary Supplement: Standard RUTF']}, {'type': 'EXPERIMENTAL', 'label': 'Soy-based RUTF', 'description': 'This is an interventional arm of the trial, in which children will receive an alternative formulation, a soy-based RUTF', 'interventionNames': ['Dietary Supplement: Soy-based RUTF']}, {'type': 'EXPERIMENTAL', 'label': 'Soy-maize-sorghum-based RUTF', 'description': 'This is an interventional arm of the trial, in which children will receive an alternative formulation, a soy-maize-sorghum-based RUTF', 'interventionNames': ['Dietary Supplement: Soy-maize-sorghum-based RUTF']}], 'interventions': [{'name': 'Soy-based RUTF', 'type': 'DIETARY_SUPPLEMENT', 'description': 'This alternative formulation of ready-to-use therapeutic foods (RUTFs) is a peanut-free formula that includes dairy (milk powder) with added crystalline amino acids', 'armGroupLabels': ['Soy-based RUTF']}, {'name': 'Soy-maize-sorghum-based RUTF', 'type': 'DIETARY_SUPPLEMENT', 'description': 'This alternative formulation of ready-to-use therapeutic foods (RUTFs) is a peanut-free and dairy-free formula with added crystalline amino acids', 'armGroupLabels': ['Soy-maize-sorghum-based RUTF']}, {'name': 'Standard RUTF', 'type': 'DIETARY_SUPPLEMENT', 'description': 'This is the control, the standard, currently used formulation of ready-to-use therapeutic foods (RUTFs), which contains dairy and peanut ingredients', 'armGroupLabels': ['Standard RUTF']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bobo-Dioulasso', 'status': 'RECRUITING', 'country': 'Burkina Faso', 'contacts': [{'name': 'Alain Hien, MSc, PhD', 'role': 'CONTACT', 'email': 'alain.hien1@gmail.com', 'phone': '70 96 07 25', 'phoneExt': '+226'}, {'name': 'Laeticia Toe, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Rebecca Brander, MSc, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lieven Huybregts, MSc, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Health centers localted in the region of Hauts-Bassins', 'geoPoint': {'lat': 11.18064, 'lon': -4.29489}}], 'centralContacts': [{'name': 'Rebecca Brander', 'role': 'CONTACT', 'email': 'r.brander@cgiar.org', 'phone': '+1 (202) 862-5600'}, {'name': 'Lieven Huybregts', 'role': 'CONTACT', 'email': 'l.huybregts@cgiar.org'}], 'overallOfficials': [{'name': 'Laeticia Toe', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut de Recherche en Sciences de la Santé'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES', 'description': "In accordance with the International Food Policy Research Institute's policy on research data management and open access, at the time of publication of scientific articles presenting results, the fully anonymized databases will become a public good and will be made available to the scientific community, government, and partners."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'International Food Policy Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'AFRICSante', 'class': 'UNKNOWN'}, {'name': 'Institut de Recherche en Sciences de la Sante, Burkina Faso', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}