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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
PACTR201110000330271 |
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Date of registration:
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26/10/2011 |
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Primary sponsor: |
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Public title:
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The role of nutritional support of human immunodeficiency virus [retrospectively registered]
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Scientific title:
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The role of whey in nutritional upport of HIV infected patients on antiretroviral treatment: A randomized trial in Jimma, Ethiopia |
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Date of first enrolment:
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2010-07-16 |
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Target sample size:
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318 |
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Recruitment status: |
Open to recruitment: actively recruiting participa |
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URL:
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HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201110000330271 |
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Study type:
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interventional |
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Study design:
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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,
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Countries of recruitment
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South Africa
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Contacts
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Name:
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Alemseged Abdissa
Lencho |
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Address:
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Jimma University
P.O.Box 980
Jimma
Ethiopia |
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Telephone:
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+251911409074 |
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Email:
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alemseged.abdissa@ju.edu.et |
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Affiliation:
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co-prinicipal investigator |
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Name:
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Alemseged Abdissa
Lencho |
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Address:
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Jimma University
P.O.Box 980
Jimma
Ethiopia |
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Telephone:
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+251911409074 |
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Email:
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alemseged.abdissa@ju.edu.et |
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Affiliation:
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co-prinicipal investigator |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. HIV infected adults (18 years or older) commencing ART,
2. living within app 50 km from Jimma, and 3.consenting to participate.
Exclusion criteria: 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.
Age minimum:
18 Year
Age maximum:
100 Year
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV/AIDS
null
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Primary Outcome(s)
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grip strength as assessed using a dynamometer
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lean body mass as assessed using deuterium dilution test
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physical activity assessed using a combined accelerometer
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Secondary Outcome(s)
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adherence to ART and quality of life
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ART drug levels
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HIV load and CD4 counts
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IGF-1
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Secondary ID(s)
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ISRCTN32453477
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Source(s) of Monetary Support
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DANIDA
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US Diary Export Council
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