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.: PACTR201708002454355 Date of Approval: 21/07/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title MUAC cut off study
Official scientific title : program and cost implications of WHO 2006 recommended MUAC cut-off points for Acute Malnutrition management in selected woredas of Amhara and Oromia Region, Ethiopia
Brief summary describing the background and objectives of the trial At present Ethiopia defines severe acute malnutrition (SAM) and moderate acute malnutrition (MAM) in the National guidelines using mid-upper arm circumference (MUAC), < 11 cm and ¿ 11 cm and < 12 cm respectively. The alignment of Ethiopian nutrition guidelines with new criteria has potential ramifications that need careful consideration and planning. As of December 2014, a total of 14,303 health facilities were providing treatment for SAM (based on current SAM identification criteria) with over a quarter of a million children anticipated to be treated in these facilities. Given this already high caseload, changes in admission criteria and treatment protocols will have significant implications for almost all of the building blocks of the health system (service delivery, workforce, information system, supply/logistics, financing and governance). Preliminary investigation has shown that the adoption of the new criteria is likely to increase resource requirements for CMAM and may put pressure on the limited financial and human resources available for the program as well as on logistics, including transportation and storage. Taking these anticipated challenges into consideration, conducting this research will provide valuable programmatic insight and overview to inform any adoption of the new cut-off points for both SAM and MAM treatment and a basis for estimating the cost effectiveness implications of their use. This will support the MOH and all stakeholders concerned with nutrition care service to make an informed decision about any change in protocols based on robust data and information. The general objective is to assess the program and cost effectiveness implications for Ethiopia of aligning with the new global WHO and UNICEF Cut-off points for identification of acute malnutrition (AM) and for graduation from a CMAM programme
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutrition,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 30/08/2017
Actual trial start date 30/08/2017
Anticipated date of last follow up 30/01/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 1767
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
NA NA
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 using a web-based randomisation software Central randomisation Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group WHO/UNICEF new global admission and discharge criteria NA 6 month the intervention group would be managed by the new WHO/UNICEF global admission and discharge criteria 883
Control Group The present Ethiopian MAM and SAM management guideline 6 month The comparison group will be exposed to the present Ethiopian MAM and SAM management guideline. This guideline defines severe acute malnutrition (SAM) and moderate acute malnutrition (MAM)in the National guidelines using mid-upper arm circumference (MUAC), < 11 cm and ¿ 11 cm and < 12 cm respectively 883
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
all children between the age of 6-59 months None 0 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 10/04/2017 IRB/EPHI
Ethics Committee Address
Street address City Postal code Country
Gulele ADDIS ABABA 1242-5654 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. between arms difference in average monthly new admissions (comparison for OTP+SFP and sub-group analysis for OTP and SFP separately) 6 months
Primary Outcome 2. between arms difference in recovery rate (for marasmus children with MUAC <125 mm; to be calculated over a fixed period of 8 weeks combining OTP and SFP/expectative observation response and until service providers initiated discharge) 6 months
Primary Outcome 3. between arms difference in time to reaching MUAC ¿125mm (marasmus children MUAC <125mm stratified by MUAC category and including OTP and SFP responses) 6 months
Primary Outcome 4. between arms difference in proportion of children with uncomplicated SAM 6 months
Primary Outcome 5. between arms difference in total programme operating costs 6 months
Secondary Outcome 1. between arms difference in proportion of readmission after being declared cured 6 months
Secondary Outcome 2. between arms differences in children assessed per OTP and SFP day 6 months
Secondary Outcome 3. between arms difference in defaulting rate 6 months
Secondary Outcome 4. between arms difference in morbidity 6 months
Secondary Outcome 5. between arm difference in mortality (in-programme and post-discharge mortality) 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
EPHI Gulele street Addis Ababa 1242-5654 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Gates foundation 440 Fifth Avenue North (East of Seattle Center Seattle, Washington United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Gates foundation 440 Fifth Avenue North (East of Seattle Center Seattle, Washington United States of America Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Valid International 35 Leopold Street Oxford OX4 1TW United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Asfaw Yosef Beyene yosef_beyene@yahoo.com +251911173618 Gullel
City Postal code Country Position/Affiliation
Addis Ababa 1242/5654 Ethiopia Associate researcher
Role Name Email Phone Street address
Public Enquiries Asfaw Yosef Beyene yosef_beyene@yahoo.com +251911173618 Gullel
City Postal code Country Position/Affiliation
Addis Ababa 1242/5654 Ethiopia Associate researcher
Role Name Email Phone Street address
Scientific Enquiries BAHWERE PALUKU paluku@validinternational.org +44 (0)1 865 722180 35 Leopold Street
City Postal code Country Position/Affiliation
OXFORD OX4 1TW United Kingdom RESEARCHER
REPORTING
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