Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202202496481398 Date of Approval: 10/02/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EFFECTIVENESS OF SIMPLIFIED APPROACH FOR THE MANAGEMENT OF WASTING AMONG CHILDREN (6-59 MONTHS) COMPARED TO STANDARD APPROACH IN ETHIOPIA: A NON-INFERIORITY RANDOMIZED CONTROLLED TRIAL
Official scientific title EFFECTIVENESS OF SIMPLIFIED APPROACH FOR THE MANAGEMENT OF WASTING AMONG CHILDREN (6-59 MONTHS) COMPARED TO STANDARD APPROACH IN ETHIOPIA: A NON-INFERIORITY RANDOMIZED CONTROLLED TRIAL
Brief summary describing the background and objectives of the trial A non-inferior Randomized Controlled Trial will be conducted on the effectiveness of a simplified approach for the Management of Wasting among children (6- 59 months) compared to the standard Approach in Ethiopia. This study aims to assess the effectiveness of a simplified approach to treat uncomplicated SAM and MAM compared to the standard of care (separate SAM and MAM treatments). The study will be conducted in three woredas from three regions: Kelela, Kersa, and Dila Zuria woredas of Amhara, Oromia, and SNNP regions, respectively in Ethiopia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 15/12/2021
Actual trial start date 15/12/2021
Anticipated date of last follow up 15/06/2022
Actual Last follow-up date 31/07/2022
Anticipated target sample size (number of participants) 1034
Actual target sample size (number of participants) 1034
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Simplified approach for the management of wasting uncomplicated SAM and MAM Use of one product – ready-to-use therapeutic food (RUTF) – to treat wasting, including both moderate and severe acute malnutrition Admission for all children with MUAC <125mm or oedema Modified dosage of RUTF) , 2 RUTF per day for children with uncomplicated SAM and RUTF per day for children with MAM 16 weeks 9 4months) Simplified approach on the Management of wasting (uncomplicated SAM and MAM) 1. Treatment of children with uncomplicated SAM Admission Criteria: Children < 115mm and/or grade + or grade ++ oedema and without medical complications, and positive appetite test. Place of treatment is at outpatient Program, Health posts. Product and dosage: is RUTF:14 sachets/per child/week (2 sachet per day), Frequency of visit and measurement: Weekly. MUAC, oedema, weight and temperature, each visit, height, will be measured at first visit and exit visit and clinic exam will be done if no gain in MUAC or presence of fever or other health problem reported. Routine treatment is as per the national guideline for the management of uncomplicated SAM 2, Treatment of Children with MAM Admission Criteria: Children 115mm - < 125mm, MAM with medical complication- manage with ICCM treatment guide for the complication. Place of treatment: at Health posts with outpatient Program. Product and dosage is RUTF: 7 sachets/per child/week (1 sachet per day). Frequency of visit and measurement is every two weeks. MUAC, oedema, weight and temperature will be measured at each visit. Height will be measured at first visit and exit visit. Clinic Exam will be done if no gain in MUAC or presence of fever or other health problem reported. Routine treatment will be given as per national guideline for the management of MAM. 517
Control Group Standard protocol for the management of wasting uncomplicated SAM and MAM Use of RUTF for the management of uncomplicated SAM and use of RUSF for the management of MAM Admission for children for uncomplicate SAM Bilateral pitting oedema + or ++ OR MUAC <11.5 cm OR WFH <-3 z-scores AND No medical complications Appetite test passed Clinically well and alert OR Referred from SC after stabilization Modified dosage of RUTF) , 2 RUTF per day for children with uncomplicated SAM and RUTF per day for children with MAM Admission criteria for Moderate Acute Malnutrition MUAC ≥11.5 to <12.5 cm OR WFH ≥ -3 to <-2 Z scores AND No bilateral pitting oedema No medical complications Clinically well and alert Dosage : RUTF base don the weight of the child RUSF: 1 sachet per day 16 weeks ( 4 months) Standard protocol for the Management of wasting (uncomplicated SAM and MAM) 1. Treatment of children with uncomplicated SAM Place of treatment is at outpatient Program, Health posts. Product and dosage: is RUTF based on weight of the child: Frequency of visit and measurement: Weekly. MUAC, oedema, weight and temperature, each visit, height, will be measured at first visit and exit visit and clinic exam will be done if no gain in MUAC or presence of fever or other health problem reported. Routine treatment is as per the national guideline for the management of uncomplicated SAM 2, Treatment of Children with MAM Place of treatment: at Health posts with outpatient Program. Product and dosage is RUSF: 7 sachets/per child/week (1 sachet per day). Frequency of visit and measurement is every two weeks. MUAC, oedema, weight and temperature will be measured at each visit. Height will be measured at first visit and exit visit. Clinic Exam will be done if no gain in MUAC or presence of fever or other health problem reported. Routine treatment will be given as per national guideline for the management of MAM. 517 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Children 6–59 months with uncomplicated acute malnutrition • MUAC <125 mm and/or • Bilateral pitting oedema (+/++) and • Passes the appetite test (consumption of some RUTF) and • No medical complications (i.e. no features of severe illness as defined by the Integrated Management of Childhood illness) • Severe anaemia is defined as hemoglobin concentration < 4g/dl. • Children with severe dehydration. • Children with hypothermia or infection. • Plans to leave the catchment area in the next 6 months. • Malformation or handicap which may affect food intake such as cleft palate, cerebral palsy, Down's syndrome Infant: 1 Month-23 Month,Preschool Child: 2 Year-5 Year 6 Month(s) 59 Month(s) Both
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
Yes 29/07/2021 Ministry of Science and Higher Education National Research Ethics Review Committee Ethiopia
Ethics Committee Address
Street address City Postal code Country
Churcher Addis Ababa, Ethiopia 1000 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Recovery rate/Cure rate at the end of the treatment
Secondary Outcome Length of stay Average weekly weight gain Average weekly MUAC gain Cost effectiveness at the end of treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kersa woreda of JImma zone Oromia region Kersa woreda, Oromia region 1000 Ethiopia
Dila Zuria Woreda of Gedio Zone Dila Zuria Woreda SNNP Region 1000 Ethiopia
Kelela Woreda of South Wollo Zone Kelela Woreda Amhara region 1000 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
UNICEF kasanchis Addis Ababa 1000 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor UNICEF Kasanchis Addis Ababa 1000 Ethiopia Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Federal Ministry of Health Tikur Anbessa Addis Ababa 1000 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Yetayesh Maru Temesgen yetayesh.maru@gmail.com +251911157593 Haile Garment
City Postal code Country Position/Affiliation
Addis Ababa 1000 Ethiopia Jimma University
Role Name Email Phone Street address
Scientific Enquiries Tefera Belachew Lema teferabelachew2@gmail.com +251917804072 Jimma
City Postal code Country Position/Affiliation
Jimma 1000 Ethiopia Jimma University
Role Name Email Phone Street address
Scientific Enquiries Kaleab Baye kaleab.baye@aau.edu.et +251911890489 Arat Kilo
City Postal code Country Position/Affiliation
Addis Ababa 1000 Ethiopia Addis Ababa University
Role Name Email Phone Street address
Scientific Enquiries Desalegn Tamiru dessalegn97@gmail.com +251912373397 Jimma
City Postal code Country Position/Affiliation
Jimma 1000 Ethiopia Jimma University
Role Name Email Phone Street address
Public Enquiries Frezer Abebe nutritionexpert12@gmail.com +251911836206 Tikur Anbessa
City Postal code Country Position/Affiliation
Addis Ababa 1000 Ethiopia Ministry of Health
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the de-individual participant data with all coding will be available upon request Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol within a year of completion of study The data will be availed for scientific use only upon formal request to the PI.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information