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.: PACTR201505001101224 Date of Registration: 15/04/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Innovative SMS-RUTF
Official scientific title Acceptability and Efficacy of an Innovative Soya Maize Based RUTF for the Treatment of Severe Acute Malnutrition
Brief summary describing the background and objectives of the trial Severe Acute Malnutrition (SAM) affects approximately 19 million children under the age of 5 and is associated with between one and two million preventable child deaths each year. In most developing countries, Case Fatality Rates (CFRs) in hospitals treating SAM remain at 20-30% many years after the standardised WHO protocol has became available and few of those requiring care actually access treatment. Ready to Use Therapeutic Foods (RUTF) have been used widely in Community based Management of Acute Malnutrition programmes (CMAM) to treat SAM as outpatients in resource-poor settings. Hitherto, most of the RUTF used in CMAM programmes uses cow milk as the main protein source. The use of cow milk at 25% by weight of the final product in these formulations makes them too expensive for sustainable use in resource-poor settings. In addition it makes local production complex and costly. At the same time attempt to produce free or low milk content RUTFs has yielded contrasting results with the most promising formulation being as effective as the standard formulation only in children aged 24 months or more. Thus, innovative free or low cow milk alternatives are needed. The goal of this research programme is to assess the efficacy of two innovative Soya-Maize-Sorghum RUTFs for the treatment of SAM in children under five years old. The two products are the new version of the Milk Free Soya-Maize RUTF (FSMS-RUTF) and the 10% Milk Soya-Maize-Sorghum RUTF (MSMS-RUTF). The new SMS-RUTF has an improved AA profile compared to the previous milk free SMS-RUTF. CMAM programming has been shown to reduce SAM related mortality from 20-30% to below 5% while increasing programme coverage from below 10% to around 50%. It has also been shown that health benefits may extend to achieving better long term survival than the general population of the same age and same community. Thus, availability of efficacious cheaper RUTF will have a huge public health impact.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,SEVERE ACUTE MALNUTRITION
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 15/08/2015
Actual trial start date
Anticipated date of last follow up 30/04/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 1200
Actual target sample size (number of participants) 1200
Recruitment status Completed
Publication URL https://www.ncbi.nlm.nih.gov/pubmed/28814393
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 radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group MSMS-RUTF 200 kcal/kg/day until cure (approximatevely 8 weeks) therapeutic feeding using experimental1 RUTF (Low milk SMS-RUTF) 400
Experimental Group FSMS-RUTF 200 kcal/kg/day until cure (approximatevely 8 weeks) therapeutic feeding using experimental2 RUTF (no milk SMS-RUTF) 400
Control Group P-RUTF 200 kcal/kg/day until cure (approximatevely 8 weeks) therapeutic feeding using the standard RUTF 400 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Cases -Age between 6 months and 59 months -Presence of SAM (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 Community controls - height/length-for¿age Z-score ¿-1 - no wasting and, - no chronic disease or disability - stable resident of the study area and who has no plan to move from the area - residing in the neighbourhood of children they will be matched -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 with history of any food allergy -Children with previous admission for severe acute malnutrition in the previous 3 months 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 23/03/2015 Malawi National Health Sciences Research Committee
Ethics Committee Address
Street address City Postal code Country
Capitol city, Ministry of Health Building Lilongwe3 PO BOX 30377 Malawi
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome recovery rate at discharge
Primary Outcome organoleptic acceptability End of 6 weeks acceptability trial
Secondary Outcome weight gain at discharge
Secondary Outcome Length of stay at discharge
Secondary Outcome height gain at discharge 3 months after discharge
Secondary Outcome percentage of body fat at admission, recovery and discharge
Secondary Outcome phase angle at admission, recovery and discharge
Secondary Outcome study food intake at discharge
Secondary Outcome breast milk intake 3 week into the study
Secondary Outcome haemoglobin change at discharge
Secondary Outcome gut inflammation proportion at admission, 14 days, 28 days and discharge
Secondary Outcome food related side effects end of 6 weeks acceptability trial
Secondary Outcome long term survival 12 months after discharge
Secondary Outcome replenishment of essential amino acid at discharge
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lilongwe District Lilongwe district Malawi
Mchinji District Mchinji District Malawi
Dedza District Dedza District Malawi
FUNDING SOURCES
Name of source Street address City Postal code Country
Ajinomoto-Co 1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi Kawasaki 210-8681 Japan
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Valid Nutrition 35, Leopold street Oxford OX4 1TW United Kingdom Commercial Sector/Industry
Primary Sponsor Ajinomoto Co 1-1, Suzuki-cho, Kawasaki-ku Kawasaki-shi 210-8681 Japan Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Sylvester Kathumba Capitol Hill Lilongwe 3 PO Box 30377 Malawi
McKnight Synos Hanniford Kalanda City Center Lilongwe Malawi
Kate Sadler 35, Leopold street Oxford OX4 1TW United Kingdom
Paluku Bahwere 35, Leopold street Oxford OX4 1TW United Kingdom
Steve Collins 35, Leopold street Oxford OX4 1TW United Kingdom
Peter Akomo 35, Leopold street Oxford OX4 1TW United Kingdom
Theresa Banda 35, Leopold street Oxford OX4 1TW United Kingdom
Mwayi Mwale DHO Lilongwe office Lilongwe Malawi
Salomon Jere Dedza DHO office Dedza Malawi
Chimwemwe Banda Mchinji DHO office Mchinji Malawi
Hitoshi Murakami 1-1, Suzuki-cho, Kawasaki-ku Kawasaki-ku 210-8681 Japan
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Paluku Bahwere paluku@validinternational.org +326522641 35, Leopold street
City Postal code Country Position/Affiliation
Oxford OX4 1TW United Kingdom Research programme manager
Role Name Email Phone Street address
Public Enquiries Paluku Bahwere paluku@validinternational.org +326522641 35, Leopold street
City Postal code Country Position/Affiliation
Oxford OX4 1TW United Kingdom Research programme Manager
Role Name Email Phone Street address
Scientific Enquiries Paluku Bahwere paluku@validinternational.org +3226522641 35, Leopold Street
City Postal code Country Position/Affiliation
Oxford OX4 1TW United Kingdom Research Programme Manager
REPORTING
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