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.: PACTR201108000303396 Date of Registration: 13/06/2011
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
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 Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Supportive care
Anticipated trial start date 02/02/2009
Actual trial start date 02/02/2009
Anticipated date of last follow up 11/06/2010
Actual Last follow-up date 11/06/2010
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 211
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
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-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum 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 Year(s) 40 Year(s) 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 15/10/2007 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
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
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
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rodah Morezio Zulu (PhD) rmzulu_83@yahoo.co.uk +260-977-761913 International Airport Road
City Postal code Country Position/Affiliation
Lusaka P O Box 310158 Zambia Principal Scientific Officer
Role Name Email Phone Street address
Public Enquiries Rodah M Zulu (PhD) rmzulu_83@yahoo.co.uk +260-977-761913 International Airport Road
City Postal code Country Position/Affiliation
Lusaka P O Box 310158 Zambia Principal Scientific Officer
Role Name Email Phone Street address
Scientific Enquiries Andrew Hills a.hills@qut.edu.au 61731386087 60 Musk Ave
City Postal code Country Position/Affiliation
Kelvin Grove QLD4001 Australia Prof. University of Tech., Queensland
REPORTING
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