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.: PACTR201110000331360 Date of Approval: 26/10/2011
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effect of prebiotic supplementation on disease progression and anthropometric status of HIV positive ARV naïve adults attending a wellness program
Official scientific title The effect of prebiotic supplementation on disease progression and anthropometric status of HIV positive ARV naïve adults attending a wellness program in KwaZulu-Natal, South Africa
Brief summary describing the background and objectives of the trial Treatment to curtail disease progression in well HIV infected individuals is lacking. There is no therapy directed at protecting the gastrointestinal tract which the HIV virus targets. Prebiotics have been shown to promote gastrointestinal health. The objectives are to compare changes in CD4+ cell count, haemoglobin, c-reactive protein, albumin, intestinal permeability, morbidity and anthropometric status in those who received prebiotics for 6 months to those who received placebo
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Treatment: Drugs
Anticipated trial start date 05/05/2012
Actual trial start date
Anticipated date of last follow up 05/01/2013
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 84
Recruitment status Completed
Publication URL
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 permuted block randomisation (10 blocks of 10) Numbered sachets Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised permuted block randomisation (10 blocks of 10) Numbered sachets 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 Inulin-type fructans 15 g per day 3 months Soluble fibre 41
Control Group Placebo None 3 months Control 43 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
HIV infected ARV naïve adults Between 18 to 44 years of age CD4+ count of >350 cells/mm3 Pregnant/lactating women Hepatic/renal insufficiency Chronic disease eg cancer, diabetes, cardiac Taking antibiotics for up to 1 month before beginning the trial Under 18 years and over 44 years Postmenopausal women CD4 counts <350 cells/mm3 Taking ARV/HAART Consuming dietary supplements with either pre or probiotics for up to 1 month before beginning the trial 18 Year(s) 70 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
No 04/11/2011 BREC
Ethics Committee Address
Street address City Postal code Country
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Changes in the incidence of diarrhoea and in quality of life Baseline Completion of study (6 months)
Secondary Outcome Changes in anthropometry and fat free mass Baseline Completion of study (6 months)
Primary Outcome To compare changes in microbial translocation by detecting changes in the concentrations of both lipopolysaccharide (LPS) and soluble CD14 (sCD14) in participants in the inulin-type fructans versus placebo group. Baseline and 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Prince Mshiyeni Memorial Hospital Mangosuthu Highway Durban 4060 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
University of KwaZulu Natal Competetive Research Grant University of Durban Westville Westville 3630 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of KwaZulu Natal Durban Road Pietermaritzburg 3201 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Department of Health 330 Langalibalele Street Pietermaritzburg 3201 South Africa
IAEA Palais des Nations Geneva Switzerland
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Chara Biggs biggsc@ukzn.ac.za +27 33 2606153 Durban Road
City Postal code Country Position/Affiliation
Pietermartizburg 3201 South Africa University of KwaZulu-Natal
Role Name Email Phone Street address
Public Enquiries Chara Biggs biggsc@ukzn.ac.za +27 33 2606153 Durban Road
City Postal code Country Position/Affiliation
Pietermaritzburg 3201 South Africa University of KwaZulu Natal
Role Name Email Phone Street address
Scientific Enquiries Chara Biggs biggsc@ukzn.ac.za +27 33 2606153 Durban Road
City Postal code Country Position/Affiliation
Pietermaritzburg 3201 South Africa University of KwaZulu-Natal
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information