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.: PACTR201110000330271 Date of Registration: 26/10/2011
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The role of nutritional support of human immunodeficiency virus [retrospectively registered]
Official scientific title The role of whey in nutritional upport of HIV infected patients on antiretroviral treatment: A randomized trial in Jimma, Ethiopia
Brief summary describing the background and objectives of the trial This is a randomized nutritional supplementation trial among adult HIV patients in Jimma, Ethiopia, commencing antiretroviral treatment (ART). The objective is to assess the effect of a whey¿containing nutritional supplement to HIV infected patients commencing antiretroviral treatment (ART) on general and HIV¿specific treatment outcomes. All patients will receive three months of ready to use supplementary food (RUSF) covering approximately half of their daily energy need and with at least 50% of the protein coming from whey. As the optimal timing of nutritional support is unknown, patients that are not defined as wasted will be randomized to receive the food supplement in the first three or the subsequent three months on ART, respectively. The design makes it possible to compare the effect of a whey¿ with a soy containing nutritional supplement, with no supplement, and compare early with late supplementation
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ARTFOOD
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Supportive care
Anticipated trial start date 16/07/2010
Actual trial start date 16/07/2010
Anticipated date of last follow up 28/02/2013
Actual Last follow-up date
Anticipated target sample size (number of participants) 350
Actual target sample size (number of participants) 318
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
ISRCTN32453477 Current Controlled Trials
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Random allocation sequences in blocks of 18 are generated, separately for the four strata. The RUSF containers are labeled from the factory using a concealment key according to whether it contains whey or soy, 3 different letters for soy and 3 for whey 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 BMI less than or equal to 17 kg/m2 Group 1 RUSF with whey 30g per day first three months supplementation, nothing in following 3 months RUSF with whey packaged in 100g sachets (2 provided daily) 25
Experimental Group BMI less than or equal to 17 kg/m2 Group 2 RUSF with soy 30 g per day first three months supplementation, nothing in following 3 months RUSF with whey packaged in 100g sachets (2 provided daily) 25
Experimental Group BMI >17 kg/m2 Group 3 RUSF with whey 30g per day first three months supplementation, nothing in following 3 months RUSF with whey packaged in 100g sachets (2 provided daily) 100
Experimental Group BMI >17 kg/m2 Group 4 RUSF with soy 30 g per day first three months supplementation, nothing in following 3 months RUSF with soy packaged in 100g sachets (2 provided daily) 100
Experimental Group BMI >17 kg/m2 Group 5a RUSF with whey 30g per day first three months no supplementation and following three months supplementation RUSF with whey packaged in 100g sachets (2 provided daily) 50
Experimental Group BMI >17 kg/m2 Group 5b RUSF with soy 30g per day first three months no supplementation and following three months supplementation RUSF with soy packaged in 100g sachets (2 provided daily) 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. HIV infected adults (18 years or older) commencing ART, 2. living within app 50 km from Jimma, and 3.consenting to participate. 1.Pregnant or lactating, terminally ill from HIV or other serious condition, 2.patients who may not be able to consume RUSF due to extensive oral lesion 3.patients with nutritional edema. 4.Patients taking micronutrient supplements or RUTF will be excluded. 18 Year(s) 100 Year(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 26/08/2009 National Health Research Ethics Review Committee, Ethiopia
Ethics Committee Address
Street address City Postal code Country
Addis Ababa Addis Ababa P.O.Box 2490 Ethiopia
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 16/01/2009 The Danish The Danish National Committee on Biomedical Research Ethics
Ethics Committee Address
Street address City Postal code Country
DK-1216 Copenhagen DK-1216 Denmark
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome lean body mass as assessed using deuterium dilution test Baseline 3 month 6 month 12 month
Primary Outcome grip strength as assessed using a dynamometer Baseline 3 month 6 month 12 month
Primary Outcome physical activity assessed using a combined accelerometer Baseline 3 month 6 month 12 month
Secondary Outcome ART drug levels 1 month 2 month
Secondary Outcome HIV load and CD4 counts Baseline 2 month 3 month 6 month
Secondary Outcome adherence to ART and quality of life Baseline 3 month 4 month 5 month 6 month 12 month
Secondary Outcome IGF-1 Baseline 3 month 6 month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Jimma Health Center Jimma Ethiopia
Jimma University Hospital Jiren Jimma P.O.Box 378 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
US Diary Export Council 2101 Wilson Blvd. Suite 400 Arlington VA 22201-3061 United States of America
DANIDA Asiatisk Plads 2 Copenhagen DK-1448 Denmark
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Prof. Kim Fleischer Michaelsen , Department of Human Nutrition, University of Copenhagen Rolighedsvej 30, Frederiksberg Copenhagen 1958 Denmark University
COLLABORATORS
Name Street address City Postal code Country
Dr Tsinuel Grima Jimma University Jimma 378 Ethiopia
Alemseged Abdissa Jimma University Jimma 980 Ethiopia
Dr Pernille Kaestel Rolighedsvej 30 Copenhagen 1958 Denmark
Mette Olsen Rolighedsvej 30 Copenhagen 1958 Denmark
Dr Daniel Yilma Jimma University Jimma 889 Ethiopia
Dr Christian Mølgaard Rolighedsvej 30, Frederiksberg Copenhagen 1958 Denmark
Dr Markos Tesfaye Jimma University Jimma P.O.Box 378 Ethiopia
Prof. Åse Bengaard Andersen Odense University Hospital Odense 5000 Denmark
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Henrik Friis hfr@life.ku.dk +45 35 33 24 70 Rolighedsvej 30, Frederiksberg
City Postal code Country Position/Affiliation
Copenhagen 1958 Denmark Prof. in Human Nutrition
Role Name Email Phone Street address
Public Enquiries Alemseged Abdissa Lencho alemseged.abdissa@ju.edu.et +251911409074 Jimma University
City Postal code Country Position/Affiliation
Jimma P.O.Box 980 Ethiopia co-prinicipal investigator
Role Name Email Phone Street address
Scientific Enquiries Alemseged Abdissa Lencho alemseged.abdissa@ju.edu.et +251911409074 Jimma University
City Postal code Country Position/Affiliation
Jimma P.O.Box 980 Ethiopia co-prinicipal investigator
REPORTING
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