Nigeria Clinical Trial Registry Federal Ministry of Health Federal Secretariat Complex Shehu Shagari Way, Garki, Abuja Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836 Email: info@nhrec.ne Trial No: 0 Date registered: 2025-03-07 Trial Status: Pending TRIAL DESCRIPTION Public title A TRIAL OF LOCALLY DEVMANAGEMENT OF ACUTE MALNUTRITION IN UNDER-FIVES WITH LOCALLY DEVELOPED NUTRITIELOPED READY-TO-USE THERAPEUTIC FOOD FOR THE MANAGEMENT OF ACUTE MALNUTRITION IN UNDER-FIVE CHILDREN Official scientific title MANAGEMENT OF ACUTE MALNUTRITION IN UNDER-FIVES WITH LOCALLY DEVELOPED NUTRITIONAL THERAPEUTIC FOOD: A CLINICAL TRIAL Brief summary describing the background and objectives of the trial Trial of locally developed ready-to-use therapeutic food (RTUF) for the management of acute malnutrition in under-five children General Objective  To compare the effectiveness of 2 variants of FIIRO produced RUTFs and Tom-Brown formulation produced in UCH, Ibadan with the gold standard - commercially produced RUTF in the management of acute malnutrition in children aged 6 months to 5 years over a 6 week period. To assess the number of children who recover from malnutrition following this Type of trial Treatment Acronym (If the trial has an acronym then please provide) A TRIAL OF LOCALLY DEVMANAGEMENT OF ACUTE MALNUTRITION IN UNDER-FIVES WITH LOCALLY DEVELOPED NUTRITIELOPED READY-TO-USE THERAPEUTIC FOOD FOR THE MANAGEMENT OF ACUTE MALNUTRITION IN UNDER-FIVE CHILDREN Disease(s) or condition(s) being studied MALNUTRITION Purpose of the trial Anticipated trial start date 2025-03-03 Actual trial start date 2025-03-10 Anticipated date of last follow up 2025-10-13 Actual date of last follow up 2025-12-01 Anticipated target sample size (number of participants) 100    Actual target sample size (number of participants) 100    Recruitment status Open to recruitment: actively recruiting participants No Secondary ID Issuing authority/Trial register 1 1 1 STUDY DESIGN Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used Single group Non-randomised 1 sealed opaque envelopes. 1 Participants,Outcome Assessors,1 INTERVENTIONS Intervention type Intervention name Dose Duration Intervention description Group size Nature of control Experimental group dgrviwoa 1 1 1 Active Control group nbmxyaxi 1 1 1 Active Experimental group opicgrhh 1 1 1 Placebo Control group oeqonksh 1 1 1 Placebo Experimental group bkvtlsmy 1 1 1 Historical Control group lrjwbdsa 1 1 1 Uncontrolled Experimental group djkfgswy 1 1 1 Uncontrolled Control group fwedfgae 1 1 1 Historical Experimental group ncbfnmyn 1 1 1 Dose comparison Control group uoqkquom 1 1 1 Dose comparison ELIGIBILITY CRITERIA List inclusion criteria List exclusion criteria Min age Max age Gender 1 1 1 1 1 ETHICS APPROVAL Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee OUTCOMES Type of outcome Outcome Timepoint(s) at which outcome measured Secondary Outcome 1 1 RECRUITMENT CENTRES Name of recruitment centre Street address City Postal code Country 1 3137 Laguna Street San Francisco 94102 Afghanistan 1 3137 Laguna Street San Francisco 94102 Albania 1 3137 Laguna Street San Francisco 94102 Algeria FUNDING SOURCES Name of source Street address City Postal code Country SPONSORS Sponsor level Name Street address City Postal code Country Nature of sponsor COLLABORATORS Name Street address City Postal code Country katana katana katana 0 CONTACT PEOPLE Role Name Email Phone Fax