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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201303000475166 Date of Registration: 14/12/2012
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title SMS-RUTF efficacy
Official scientific title Efficacy of Soya Maize Based RUTF in Treating Severe Acute Malnutrition in Children Under-Five in South Kivu, Eastern Democratic Republic of Congo
Brief summary describing the background and objectives of the trial Ready to Use Therapeutic Foods (RUTF) have been used widely to treat severe acute malnutrition (SAM) in children and its used has been associated with a significnt reduction in case fatality. But, currently the RUTF used in most programmes is peanut and milk-based and is too expensive for sustainable use in resource-poor settings. Thus, alternative formulations are needed and the present study asseses the efficacy of a soya-maize-Sorghum RUTF that is peanut and milk free and cheaper.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,Paediatrics,severe acute malnutrition
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 19/12/2012
Actual trial start date 03/01/2013
Anticipated date of last follow up 31/07/2014
Actual Last follow-up date 30/04/2014
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants)
Recruitment status Completed
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 randomisation using a randomisation table created by a computer software programme with separate tables for under 24 months and 24 months and over sealed opaques envoloppe prepared by the supervisor who will not be involved in group allocation Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group SMS-RUTF arm 170 Kcal/kg/day in four to five meals per day and 7 days per week. until nutrition recovery (anticipated average is 8 weeks) therapeutic feeding with SMS-RUTF using the day care approach 382
Control Group P-RUTF arm 170 kcal/kg/day in 4 to 5 meals 7days/week. until recoverage (anticipated average is 8 weeks) Therapeutic feeding with standard RUTF (P-RUTF) using the day care approach 382 Active-Treatment of Control Group
Control Group Community comparison No intervention Follow up for 12 months Children from the community will be matched with children discharged from the therapeutic feeding intervention and follwed up during 12 months to assess morbidity, mortality and nutrition status evolution 535 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
For the intervention and active control arms -Age between 6 months and 59 months -Presence of SAM defined by MUAC<115mm or presence of bilateral pitting oedema of any grade or presence of clinical signs of wasting confirmed by the supervisor. -Residing within 1 hour walking distance from the day-care centre -Caregivers consent to participate For the community control arm -well-nourished children with no history of treatment for acute malnutrition who are stable resident of the study area -caregivers consent to participate -matching the case for age, gender, village, height and HIV status. -Presence of disability including congenital or acquired disorders affecting growth -Refusal to participate -Children of visiting families who risk to return to their location before completing the study -Children from villages distant from the therapeutic feeding centres by more than one hour walk -Children with history of any food allergy -Children with previous admission for severe acute malnutrition in the previous 3 months -children with chronic diseases such us sickle cells anemia, mental disability and cardiac or reanal disease. 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 07/12/2012 Ethic committtee of the Catholic University of Bukavu
Ethics Committee Address
Street address City Postal code Country
Diocese, Bukavu Bukavu BP 285 Democratic Republic of the Congo
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome recovery rate at discharge from the therapeutic feeding phase
Secondary Outcome weight gain (weight velocity) At discharge from the therapeutic feeding phase
Secondary Outcome lenght of stay in therapeutic feeding phase At discharge from therapeutic feeding phase
Secondary Outcome fat free mass proportion at discharge from therapeutic feeding phase
Secondary Outcome Height gain At discharge from therapeutic feeding phase and 3 months after discharge from therapeutic feeding phase
Secondary Outcome aneamia rate at discharge from therapeutic feding phase
Secondary Outcome 12 months survival after discharge from nutrition therapeutic feeding programme 12 months after being discharge from therapeutic feeding phase
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Miti-Murhesa health District Kavumu city centre, 10 South Kivu province 1000 Kavumu Democratic Republic of the Congo
FUNDING SOURCES
Name of source Street address City Postal code Country
Irish Aid Dublin Ireland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Valid Nutrition 35, Leopold Street Oxford OX4 1TW United Kingdom Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Paluku Bahwere Fond Tasnier, 6 Genval 1332 Belgium
Steve Collins 35, Leopold Street Oxford OX4 1TW United Kingdom
Kate Sadler 35, Leopold Steet OXFORD OX4 1TW United Kingdom
Filippo Dibari 35, Leopold Street Oxford OX4 1TW United Kingdom
Peter Akomo 35, Leopold Street Oxford OX4 1TW United Kingdom
Michèle Dramaix 808, Route de Lennik Bruxelles 1070 Belgium
Bisimwa Balaluka Bukavu Democratic Republic of the Congo
Chobohwa Lwiro Democratic Republic of the Congo
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Paluku Bahwere paluku@validinternational.org +32473199353 Fond Tasnier,6
City Postal code Country Position/Affiliation
Genval 1332 Belgium Research coordinator
Role Name Email Phone Street address
Public Enquiries Paluku Bahwere paluku@validinternational.org +32473199253 Fond Tasnier,6
City Postal code Country Position/Affiliation
Genval 1332 Belgium Research coordinator
Role Name Email Phone Street address
Scientific Enquiries Paluku Bahwere paluku@validinternational.org +32473199353 Fond Tasnier 6
City Postal code Country Position/Affiliation
Genval 1332 Belgium Research coordinator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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