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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: www.pactr.org

Trial no.: PACTR201303000475166 Date registered: 2012/12/14
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
Purpose of the trial Treatment
Anticipated trial start date 2012-12-19
Actual trial start date 2013-01-03
Anticipated date of last follow up 2014-07-31
Actual date of last follow up 2014-04-30
Anticipated target sample size (number of participants) 764/536   
Actual target sample size (number of participants)   
Recruitment status Temporary halt or suspension
Secondary Ids Issuing authority/Trial register Links to Secondary ID

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
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
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

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max 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 Months 59 Months 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 2012/12/07 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 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
Secondary Outcome weight gain (weight velocity) At discharge from the 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 Company

COLLABORATORS
Name Street address City Postal code Country
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
Paluku Bahwere Fond Tasnier, 6 Genval 1332 Belgium
Steve Collins 35, Leopold Street Oxford OX4 1TW United Kingdom

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Dr Paluku Bahwere paluku@ validinternational.org +32473199353
Street address City Postal code Country Position / Affiliation
Fond Tasnier,6 Genval 1332 Belgium Research coordinator
Role Name Email Phone Fax
Public Enquiries Dr Paluku Bahwere paluku@ validinternational.org +32473199253
Street address City Postal code Country Position / Affiliation
Fond Tasnier,6 Genval 1332 Belgium Research coordinator
Role Name Email Phone Fax
Scientific Enquiries Dr Paluku Bahwere paluku@ validinternational.org +32473199353
Street address City Postal code Country Position / Affiliation
Fond Tasnier 6 Genval 1332 Belgium Research coordinator