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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.: PACTR201108000303396 Date registered: 2011/06/13
TRIAL DESCRIPTION
Public title Assessing the impact of food supplement on nutritional status of HIV infected people on ARVS in Zambia [retrospectively registered]
Official scientific title Evaluating metabolic composition of HIV infected poeple on ARVs in Zambia
Brief summary describing the background
and objectives of the trial
Prevalences rates of HIV in Zambia is high at 14%. Poor nutritional status has worsened this situation. Government has instigated a number of strategies including provision of ARVs coupled with good nutrition. High energy protein supplement (HEPS) is promoted. Impact of HEPS on nutrition status beyond body weight gain has not been assessed. This study aims to assess impact of HEPS on nutritional status using comprehensive anthropometric and criterion deuterium dilution and BIA techniques.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ZAM6/013
Disease(s) or condition(s) being studied HIV/AIDS ,
Purpose of the trial Supportive care
Anticipated trial start date 2009-02-02
Actual trial start date 2009-02-02
Anticipated date of last follow up 2010-06-11
Actual date of last follow up 2010-06-11
Anticipated target sample size (number of participants) 200   
Actual target sample size (number of participants) 211   
Recruitment status Closed to recruitment: follow up complete
Secondary Ids Issuing authority/Trial register Links to Secondary ID
Ref: 017-02-07 University of Zambia Research Ethics Committee (UNZAREC)

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 Simple randomisation where the sister incharge would write on half the papers "soya" and half "no soya" fold and mixed them than participants would pick one paper and read out the choice. N/A Open-label (masking not used)

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group Food supplement (HEPS) Consume twice a day 12 months One group was given food supplement (Experimental group) while the other group was not (control) 110
Control group Control No food supplement given Control 101 Active

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
HIV positive with CD4 count 250 cells/ul or less Eligible to commence ARV treatment Female aged 20-40 Not mentally challenged Agree to participate Clinically unstable or with other medical conditions (e.g. elevated creatinine) Pregnant or plan to fall pregnant during the study 20 Years 40 Years Female

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 2007/10/15 University of Zambia Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Ridgeway Campus Lusaka P O Box 50110 Zambia

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Nutritional status Baseline at 4 months follow-up at 8 months follow-up at 12 months follow-up
Secondary Outcome Change in Body Composition Baseline at 4 months follow-up at 8 months follow-up at 12 months follow-up
Secondary Outcome Immune status Baseline at 4 months follow-up at 8 months follow-up at 12 months follow-up
Secondary Outcome Micronutrient status Baseline at 12 months follow-up

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Matero Reference Clinic Lusaka Zambia

FUNDING SOURCES
Name of source Street address City Postal code Country
International Atomic Energy Agency Wagramer Strasse 5 Vienna P O Box 100, A-1400 Austria
Ministry of Science Technology and Vocational Training Los Angeles Boulevard, Road Longacres Lusaka P O Box 50464 Zambia

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor International Atomic Energy Agency Wagramer Strasse 5 Vienna P O Box 100, A-1400 Austria Funding Agency

COLLABORATORS
Name Street address City Postal code Country
Musonda Mofu National Food and Nutrition Commission, Lumumba Road Lusaka P O Box 32669, Zambia
Justin Chileshe Tropical Diseases Research Centre, 6th Floor Ndola Central Hospital Ndola P O Box 71769 Zambia
University of Zambia, Physics Dept and Food Science and Technolgy Dept Great East Road Campus Lusaka P O Box 32379 Zambia
Lusaka District Health Management Teamnt Makishi Road Lusaka P O Box 50827 Zambia
Prof Andrew P Hills Queensland University of Technology, Institute of Health and Biomedical Innovation, 60 Musk Avenue, Kelvin Grove Brisbane QLD 4001 Australia
James Chipeta MD University of Zambia, School of Medicine, Department of Paediatrics and Child Health Lusaka P O Box 50110 Zambia

CONTACT PEOPLE
Role Name Email Phone Fax
Scientific Enquiries Prof Andrew Hills a.hills@qut.edu.au 61731386087 61435694787
Street address City Postal code Country Position / Affiliation
60 Musk Ave Kelvin Grove QLD4001 Australia Prof. University of Tech., Queensland
Role Name Email Phone Fax
Public Enquiries Ms Rodah M Zulu (PhD) rmzulu_83@yahoo.co.uk +260-977-761913 +260 (211) 281013
Street address City Postal code Country Position / Affiliation
International Airport Road Lusaka P O Box 310158 Zambia Principal Scientific Officer
Role Name Email Phone Fax
Principal Investigator Ms Rodah Morezio Zulu (PhD) rmzulu_83@yahoo.co.uk +260-977-761913 +260 (211) 281013
Street address City Postal code Country Position / Affiliation
International Airport Road Lusaka P O Box 310158 Zambia Principal Scientific Officer