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.: PACTR201106000300631 Date of Approval: 31/05/2011
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title NUSTART
Official scientific title Nutritional support for African adults starting antiretroviral therapy
Brief summary describing the background and objectives of the trial We have preliminary evidence that early death in African adults initiating ART is related to nutritional status. This is an RCT of a micronutrient and mineral (potassium, phosphate, magnesium) intervention. Primary outcome is death, and hospitalisation and nutritional recovery are important secondary outcomes.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) NUSTART
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 06/06/2011
Actual trial start date 29/08/2011
Anticipated date of last follow up 29/11/2013
Actual Last follow-up date
Anticipated target sample size (number of participants) 2300
Actual target sample size (number of participants) 1814
Recruitment status Completed
Publication URL doi: 10.1186/s12916-014-0253-8
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 Simple randomisation using a randomisation table created by a computer software programme Numbered containers generated by DSMB statistician off-site 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 Micronutrient and mineral supplement Multiple constituents: approximately 3 x RNI Approximately 8 weeks Two-stage supplement using lipid-based pastes 1150
Control Group Placebo Placebo Approximately 8 weeks Two-stage placebo supplement using lipid-based pastes 1150
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
at least 18 years old; ART-naive (except for standard regimens to prevent maternal-to-child HIV transmission); BMI < 18.5 kg/m2. In the presence of clinical oedema and a BMI < 20 kg/m2, BMI will be re-measured after loss of oedema, and the patient considered eligible if BMI < 18.5 kg/m2 and ART has not yet been initiated; requiring ART as determined by CD4 count < 350/ul or stage 3 or 4 disease; willing to undertake intensive ART follow-up in the study clinic; providing written, fully informed consent (thumbprint will be accepted) participation in a potentially conflicting research protocol; pregnancy (by self-report) 18 Year(s) 80 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 24/03/2011 Medical Research Coordinating Comittee
Ethics Committee Address
Street address City Postal code Country
National Institute for Medical Research P.O. Box 9653 Dar es Salaam Dar es Salaam PO Box 90 Tanzania
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 12/04/2011 University of Zambia Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Ridgeway Campus Lusaka 50110 Zambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mortality 12 weeks after starting ART
Secondary Outcome Hospitalisation Between recruitment and 12 weeks after starting ART
Secondary Outcome Any SAE Before 12 weeks after starting ART
Secondary Outcome Weight gain 6 and 12 weeks after starting ART
Secondary Outcome Appetite 6 weeks after starting ART
Secondary Outcome Grip strength 6 and 12 weeks after starting AR
Secondary Outcome Change in fat-free mass and fat mass 6 and 12 weeks after starting ART
Secondary Outcome Plasma electrolytes 0,2,6,and 12 weeka after starting ART
Secondary Outcome Iron status 6 weeks after starting ART in a subgroup of participants
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Natinoal Institute for Medical Research Mwanza Tanzania
University Teaching Hospital Nationalist Road Lusaka Zambia
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor London School of Hygiene & Tropical Medicine Keppel Street London WC1E 7HT United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Suzanne Filteau LSHTM, Keppel Street London WC1E 7HT United Kingdom
Henrik Friis Institute of Nutrition, University of Copenhagen Copenhagen Denmark
Paul Kelly Barts & The London School of Medicine, Turner St London E1 2AD United Kingdom
John Changalucha NIMR Mwanza Mwanza PO Box 1462 Tanzania
Lackson Kasonka University Teaching Hospital Lusaka 10110 Zambia
Doug Heimburger Vanderbilt University Institute for Global Health, 2525 West End Avenue, Suite 750 Nashville 37203 United States of America
Tsinuel Girma Jimma University Specialised Hospital Jimma PO Box 94 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Suzanne Filteau suzanne.filteau@lshtm.ac.uk +44 20 7958 8108 London School of Hygiene & Tropical Medicine
City Postal code Country Position/Affiliation
London WC1E 7HT United Kingdom Professor of International Nutrition
Role Name Email Phone Street address
Public Enquiries Yolanda Fernandez Yolanda.Fernandez@lshtm.ac.uk +44 20 7958 8108 Keppel Street
City Postal code Country Position/Affiliation
London WC1E 7HT United Kingdom Project Administrator
Role Name Email Phone Street address
Scientific Enquiries Suzanne Filteau suzanne.filteau@lshtm.ac.uk +44 20 79588108 LSHTM, Keppel St
City Postal code Country Position/Affiliation
London WC1E 7HT United Kingdom
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD data are not available Clinical Study Report N/A N/A
URL Results Available Results Summary Result Posting Date First Journal Publication Date
doi: 10.1186/s12916-014-0253-8 Yes 26/08/2024 28/01/2015
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 26/08/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information