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.: PACTR201308000562388 Date of Approval: 13/06/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title WPC-RUTF acceptability and effectiveness
Official scientific title Acceptability and effectiveness of Milk Whey protein based Ready-To-Use Therapeutic Food in treatment of severe acute malnutrition in under-five
Brief summary describing the background and objectives of the trial Ready-to-Use Therapeutic Food (RUTF) combined with the Community-based Therapeutic Care (CTC) delivery mechanism has had enormous impact on the performances of programmes addressing severe acute malnutrition (SAM). Currently, CTC programmes rely on paste RUTF made with milk powder. The intensive use of milk powder in this RUTF makes it cost-prohibitive. The aim of this study is to assess the acceptability and effectiveness of a RUTF in which milk powder is replaced by whey protein concentrates.
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 01/03/2010
Actual trial start date 15/03/2010
Anticipated date of last follow up 30/09/2010
Actual Last follow-up date 31/03/2011
Anticipated target sample size (number of participants) 600
Actual target sample size (number of participants) 595
Recruitment status Completed
Publication URL http://onlinelibrary.wiley.com/doi/10.1111/mcn.12112/full
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 sealed opaque enveloppe Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group WPC-RUTF 150-200 kcal/kg/day until cured therapeutic feeding 303
Control Group P-RUTF 150-200 Kcal/kg/day Until cured therapeutic feeding 292 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
MUAC<110mm Bilateral pitting oedema Weight-for-height <70% >=6 and <60 months of age < 6 months of age >59 months of age Neurological disability inability to eat solid food Allergy to peanut Refusal to sign consent form 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 28/09/2009 National Health Science Research Committee, Ministry of Health and Population
Ethics Committee Address
Street address City Postal code Country
City Centre, Ministry of Health Lilongwe 30337, Lilongwe3 Malawi
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome weight gain At discharge from the programme
Secondary Outcome Recovery rate At discharge from the programme
Secondary Outcome MUAC gain At discharge from the programme
Secondary Outcome Length of stay At discharge from the programme
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lilongwe Health District Lilongwe rural Malawi
FUNDING SOURCES
Name of source Street address City Postal code Country
U.S Diary Export Council (USDEC) 2101, Wilson Boulevard suite 400 Arlington, Virginia 22201-3061 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor U.S Diary Export Council (USDEC) 2101, Wilson Boulevard suite 400 Arlington, Virginia 22201-3061 United States of America Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Paluku Bahwere Fond Tasneir, 6 Genval 1332 Belgium
Theresa Banda Umodzi Road, 12/86 Lilongwe X339 Malawi
Gertrude Nyirenda Umodzi Road, 12/86 Lilongwe X339 Malawi
Bina Shaba Umodzi Road, 12/86 Lilongwe X339 Malawi
Victor Owino Mombasa Road Nairobi 17191-00100 Kenya
Filippo Dibari 35, Leopold Street Oxford OX4 1TW United Kingdom
Steve Collins 35, Leopold Street Oxford OX4 1TW United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Paluku Bahwere paluku@validinternational.org +3226522641 Fond Tasnier, 6
City Postal code Country Position/Affiliation
Genval 1332 Belgium Research manager
Role Name Email Phone Street address
Public Enquiries Paluku Bahwere paluku@validinternational.org +3226522641 Fond Tasnier, 6
City Postal code Country Position/Affiliation
Genval 1332 Belgium Research manager
Role Name Email Phone Street address
Scientific Enquiries Paluku Bahwere paluku@validinternational.org +3226522641 Fond Tasnier, 6
City Postal code Country Position/Affiliation
Genval 1332 Belgium Research manager
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
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information