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.: PACTR202309675479831 Date of Approval: 26/09/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Modified Dosage for Acute Malnutrition
Official scientific title Safety efficacy, and cost-effectivness of modified doses of ready-to-use therapeutic and supplementary foods for the treatment of acute malnutrition among children 6-59 months of age in Ethiopia: An individually randomized controlled clinical trial
Brief summary describing the background and objectives of the trial Protocols for the community-based management of acute malnutrition (CMAM) have not changed significantly for more than 20 years, with relatively complex treatment protocols and persistent supply chain challenges that have limited overall program coverage, leaving millions of malnourished children without care annually. The overarching goal of this research project is to simultaneously test two novel simplified approaches in CMAM with potential to improve program coverage. The simplified approach includes two parallel clinical trials for the treatment of severe acute malnutiriton (SAM) and moderate acute malnutrition (MAM). Two fixed-dose regimes of ready-to-use therapeutic food (RUTF) will be tested against with the current weight-based dosing regimen of RUTF for children with SAM. Similarly, two different fixed-dose regimes of RUTF will be tested against with a standard fixed-dose regimen of ready-to-use supplementary food (RUSF) for children with MAM. Children with SAM and MAM from both trials who achieve nutritional recovery within 16 weeks will then be randomized again to one of three different follow-up arms. For this follow-up study, children who recover from these two parallel clinical trials will be enrolled in a trial to test the effectiveness of MUAC screening at home by the child’s caregivers as a self-referral strategy, compared to a scheduled health facility-led strategy and the standard of care o fcommunity-based follow-up visits.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MODAM
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 18/09/2023
Actual trial start date
Anticipated date of last follow up 06/09/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 8400
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
4982023 Ethiopian Public Health Institute Institutional Review Board
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group SAM Control Standard weight-based dosing of Ready-to-Use Therapeutic Food (RUTF) at a dose of 150-200 kcal/kg/day Until child achieves one of the pre-specified endpoints (nutritional recovery, hospitalization, death, lost to follow-up) -- at most up to 16 weeks Ready-to-Use Therapeutic Food (RUTF) -- standard formulation meeting UNICEF specifications: https://www.unicef.org/supply/sites/unicef.org.supply/files/2023-04/U239977-RUTF-Novel-Specification.pdf 800 Active-Treatment of Control Group
Experimental Group SAM Experimental A 2 sachets (1000 kcal) per day Until child achieves one of the pre-specified endpoints (nutritional recovery, hospitalization, death, lost to follow-up) -- at most up to 16 weeks Ready-to-Use Therapeutic Food (RUTF) -- standard formulation meeting UNICEF specifications: https://www.unicef.org/supply/sites/unicef.org.supply/files/2023-04/U239977-RUTF-Novel-Specification.pdf 800
Experimental Group SAM Experimental B 2 sachets (1000 kcal) per day while MUAC < 115mm and/or edema and/or WHZ < -3; then decreasing to 1 sachet per day (500 kcal) while MUAC 115-124 and WHZ -2 to -3 and no edema Until child achieves one of the pre-specified endpoints (nutritional recovery, hospitalization, death, lost to follow-up) -- at most up to 16 weeks Ready-to-Use Therapeutic Food (RUTF) -- standard formulation meeting UNICEF specifications: https://www.unicef.org/supply/sites/unicef.org.supply/files/2023-04/U239977-RUTF-Novel-Specification.pdf 800
Control Group MAM Control 1 sachet (535 kcal) per day Until child achieves one of the pre-specified endpoints (nutritional recovery, hospitalization, death, lost to follow-up, decompensation to severe acute malnutrition) -- at most up to 16 weeks Ready-to-Use Supplementary Food (RUSF) -- standard formulation meeting UNICEF specifications: https://www.unicef.org/supply/media/16636/file/S0000248-RUSF-Specification.pdf 800 Active-Treatment of Control Group
Experimental Group MAM Experimental A 1 sachet (500 kcal) per day Until child achieves one of the pre-specified endpoints (nutritional recovery, hospitalization, death, lost to follow-up, decompensation to severe acute malnutrition) -- at most up to 16 weeks Ready-to-Use Therapeutic Food (RUTF) -- standard formulation meeting UNICEF specifications: https://www.unicef.org/supply/sites/unicef.org.supply/files/2023-04/U239977-RUTF-Novel-Specification.pdf 800
Experimental Group MAM Experimental B 2 sachets (1000 kcal) per day Until child achieves one of the pre-specified endpoints (nutritional recovery, hospitalization, death, lost to follow-up, decompensation to severe acute malnutrition) -- at most up to 16 weeks Ready-to-Use Therapeutic Food (RUTF) -- standard formulation meeting UNICEF specifications: https://www.unicef.org/supply/sites/unicef.org.supply/files/2023-04/U239977-RUTF-Novel-Specification.pdf 800
Control Group Post Recovery Standard of Care 6 months nutrition, IYCF, and WASH education at discharge, followed by regular community-based screenings led by health extension workers, with one final visit scheduled at 6 months after discharge 1200 Active-Treatment of Control Group
Experimental Group Post Recovery Scheduled Followup 6 months standard of care plus scheduled follow-up visits at 1 month, 3 months, 6 months after discharge 1200
Experimental Group Post Recovery family MUAC 6 months standard of care plus Family MUAC training for the primary caregiver present at the time of recovery, with one final visit scheduled at 6 months after discharge 1200
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
SAM Cohort: 1. Age 6-59 months 2. Reside in the catchment area of the health post where the trial is to be conducted without plans to leave the area over the next year 3. Uncomplicated severe acute malnutrition, as defined by no signs of severe illness that would require referral to inpatient facility 4. Pass appetite test conducted at the time of enrollment 5. Consent for randomization into the study given by mother, father, and/or other primary caregiver 6. Mid-upper arm circumference less than 115 mm and/or nutritional edema 7. Weight-for-height Z-score (WHZ) less than -3 (will not count towards planned sample size) MAM Cohort: 1. Age 6-59 months 2. Reside in the catchment area of the health post where the trial is to be conducted without plans to leave the area over the next year 3. Uncomplicated moderate acute malnutrition, as defined by no signs of severe illness that would require referral to inpatient facility 4. Pass appetite test conducted at the time of enrollment 5. Consent for randomization into the study given by mother, father, and/or other primary caregiver 6. Mid-upper arm circumference of 115-124 mm without nutritional edema 7. Weight-for-height Z-score (WHZ) between -2 and -3 (will not count towards planned sample size) Followup Cohort: 1. Children 6-59 months of old who recovered from SAM or MAM following treatment in either of the SAM or MAM intervention trials All Cohorts: 1. Complicated acute malnutrition with severe illness requiring transfer to a stabilization center or hospital for treatment. This includes, but is not limited to: a. Hypothermia b. High fever c. Signs of hypoglycemia d. Lethargy or altered mental status e. Moderate to severe dehydration f. Shock g. Other medical complications requiring hospitalization or higher-level medical evaluation 2. Treatment for acute malnutrition, either as an inpatient or outpatient, within the past 3 months 3. Known chronic medical illness such as severe cerebral palsy, severe congenital anomalies such as unrepaired congenital heart disease, Down syndrome, hydrocephalus, unrepaired cleft lip or palate, or other conditions that would be expected to contribute to difficulty feeding the prescribed amounts of therapeutic or supplementary food. Infant: 13 Month(s)-24 Month(s),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 13/05/2023 Ethiopian Public Health Institute
Ethics Committee Address
Street address City Postal code Country
PO Box 1242/5654 Addis Ababa - Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome SAM cohort -- short-term nutritional recovery from SAM up to 16 weeks
Secondary Outcome SAM cohort -- weight gain during treatment, as measured in g, g/kg/d, WAZ, and WHZ weekly for up to 16 weeks
Secondary Outcome SAM cohort -- MUAC gain during treatment, as measured in mm, mm/d, and MUACZ weekly for up to 16 weeks
Secondary Outcome SAM cohort -- length/height gain during treatment, as measured in cm, mm/d, and HAZ weekly for up to 16 weeks
Secondary Outcome SAM cohort -- changes to body composition as measured by electrical impedance up to weekly for up to 16 weeks
Secondary Outcome SAM cohort -- changes in immunological function during treatment as measured by quantification of T-cell recombination excision circles (TRECs) and kappa-deleting recombination excision circles (KRECs) on dried blood spots up to weekly for up to 16 weeks
Secondary Outcome SAM cohort -- rates of acute illness, including diarrhea, vomiting, and fever during treatment weekly for up to 16 weeks
Secondary Outcome SAM cohort -- mortality up to 16 weeks
Secondary Outcome SAM cohort -- hospitalization up to 16 weeks
Secondary Outcome SAM cohort -- duration of treatment required prior to short-term recovery up to 16 weeks
Secondary Outcome SAM cohort -- medium-term vital and nutritional status, including rates of relapse to SAM and MAM, hospitalization, loss to follow-up, and mortality up to 6 months post-recovery
Secondary Outcome SAM cohort -- medium-term weight gain 6 months post-recovery
Secondary Outcome SAM cohort -- medium-term MUAC gain 6 months post-recovery
Secondary Outcome SAM cohort -- medium-term length/height gain 6 months post-recovery
Secondary Outcome SAM cohort -- medium-term body composition and immunological function 6 months post-recovery
Secondary Outcome SAM cohort -- short-term cost-efficiency up to 16 weeks
Secondary Outcome SAM cohort -- medium-term cost-efficiency 6 months post-recovery
Primary Outcome MAM cohort -- short-term nutritional recovery from MAM up to 16 weeks
Secondary Outcome MAM cohort -- weight gain during treatment, as measured in g, g/kg/d, WAZ, and WHZ weekly for up to 16 weeks
Secondary Outcome MAM cohort -- MUAC gain during treatment, as measured in mm, mm/d, and MUACZ weekly for up to 16 weeks
Secondary Outcome MAM cohort -- length/height gain during treatment, as measured in cm, mm/d, and HAZ weekly for up to 16 weeks
Secondary Outcome MAM cohort -- changes to body composition as measured by electrical impedance up to weekly for up to 16 weeks
Secondary Outcome MAM cohort -- changes in immunological function during treatment as measured by quantification of T-cell recombination excision circles (TRECs) and kappa-deleting recombination excision circles (KRECs) on dried blood spots up to weekly for up to 16 weeks
Secondary Outcome MAM cohort -- rates of acute illness, including diarrhea, vomiting, and fever during treatment weekly for up to 16 weeks
Secondary Outcome MAM cohort -- mortality up to 16 weeks
Secondary Outcome MAM cohort -- hospitalization up to 16 weeks
Secondary Outcome MAM cohort -- duration of treatment required prior to short-term recovery up to 16 weeks
Secondary Outcome MAM cohort -- medium-term vital and nutritional status, including rates of relapse to SAM and MAM, hospitalization, loss to follow-up, and mortality up to 6 months post-recovery
Secondary Outcome MAM cohort -- medium-term weight gain 6 months post-recovery
Secondary Outcome MAM cohort -- medium-term MUAC gain 6 months post-recovery
Secondary Outcome MAM cohort -- medium-term length/height gain 6 months post-recovery
Secondary Outcome MAM cohort -- medium-term body composition and immunological function 6 months post-recovery
Secondary Outcome MAM cohort -- short-term cost-efficiency up to 16 weeks
Secondary Outcome MAM cohort -- medium-term cost-efficiency 6 months post-recovery
Primary Outcome Followup cohort -- number of episodes of relapse to acute malnutrition identified 6 months
Secondary Outcome Followup cohort -- WHZ at time relapse to acute malnutrition identified 6 months
Secondary Outcome Followup cohort -- MUAC at time relapse to acute malnutrition identified 6 months
Secondary Outcome Followup cohort -- number of episodes of relapse to edematous malnutrition / kwashiorkor identified 6 months
Secondary Outcome Followup cohort -- recovery rates following treatment of relapse to acute malnutrition 6 months
Secondary Outcome Followup cohort -- mortality 6 months
Secondary Outcome Followup cohort -- hospitalization 6 months
Secondary Outcome Followup cohort -- loss to follow-up 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Wayu wando - Wayu wando Ethiopia
Kulcha - Kulcha Ethiopia
Elkune - Elkune Ethiopia
Bulekorma - Bulekorma Ethiopia
Bulekorma health centre - Bulekorma Ethiopia
Fulotole - Fulotole Ethiopia
Hatuse - Hatuse Ethiopia
Darge dhaba - Darge dhaba Ethiopia
Marmaro - Marmaro Ethiopia
Dibegaya health centre - Dibegaya Ethiopia
Gandhile - Gandhile Ethiopia
Makkanisa - Makkanisa Ethiopia
Hadho - Hadho Ethiopia
Milami Rural - Milami Ethiopia
Jirersa - Jirersa Ethiopia
Kulcha health centre - Kulcha Ethiopia
Buledanbi - Buledanbi Ethiopia
Hobok - Hobok Ethiopia
Dibegaya - Dibegaya Ethiopia
Bila - Bila Ethiopia
Kallo - Kallo Ethiopia
Ibsa - Ibsa Ethiopia
Kulcha town - Kulcha Ethiopia
Milami town - Milami Ethiopia
Milami health centre - Milami Ethiopia
Digino - Digino Ethiopia
Kayane - Kayane Ethiopia
Badila ad - Badila ad Ethiopia
Godirey - Godirey Ethiopia
Kunka - Kunka Ethiopia
Gabi as - Gabi as Ethiopia
Hadawe health centre - Hadawe Ethiopia
Hobyo - Hobyo Ethiopia
Ubaley - Ubaley Ethiopia
Waylasidig - Waylasidig Ethiopia
Baare - Baare Ethiopia
Doloba ad - Doloba ad Ethiopia
Dud ade - Dud ade Ethiopia
Hididole - Hididole Ethiopia
Ellan health centre - Ellan Ethiopia
Karinka - Karinka Ethiopia
Yaxasjamal - Yaxasjamal Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
UNICEF 3 United Nations Plaza New York 10017 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Action Against Hunger Togo Road Addis Ababa 2357 Ethiopia non-governmental organization
Secondary Sponsor Ethiopian Public Health Institute Sub city-Gulele/K/K, Woreda-09 Addis Ababa Ethiopia research institute
Secondary Sponsor University of Washington 4800 Sand Point Way NE, M/S MB.7.520 Seattle 98105 United States of America University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Heather Stobaugh hstobaugh@actionagainsthunger.org +13175902717 One Whitehall St, 2nd Floor
City Postal code Country Position/Affiliation
New York 10004 United States of America Action Against Hunger Senior Research and Learning Specialist
Role Name Email Phone Street address
Principal Investigator Indi Trehan indi@alum.berkeley.edu +12067696068 4800 Sand Point Way NE, M/S MB.7.520
City Postal code Country Position/Affiliation
Seattle 98105 United States of America University of Washington Associate Professor
Role Name Email Phone Street address
Principal Investigator Yosef Beyene yosef_beyene@yahoo.com +25191173618 Sub city-Gulele/K/K, Woreda-09
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Ethiopian Public Health Institute Associate Researcher
Role Name Email Phone Street address
Scientific Enquiries Indi Trehan indi@alum.berkeley.edu +12067696068 4800 Sand Point Way NE, M/S MB.7.520
City Postal code Country Position/Affiliation
Seattle 98105 United States of America University of Washington Associate Professor
Role Name Email Phone Street address
Public Enquiries Indi Trehan indi@alum.berkeley.edu +12067696068 4800 Sand Point Way NE, M/S MB.7.520
City Postal code Country Position/Affiliation
Seattle 98105 United States of America University of Washington Associate Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Clinical Study Report Immediately after study publication Data will be shared with verified researchers interested in meta-analyses or similar secondary analyses upon request
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