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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.: PACTR201106000300631 Date registered: 2011/05/31
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 HIV/AIDS ,
Purpose of the trial Treatment
Anticipated trial start date 2011-06-06
Actual trial start date 2011-08-29
Anticipated date of last follow up 2013-11-29
Actual date of last follow up
Anticipated target sample size (number of participants) 2300   
Actual target sample size (number of participants) 1814   
Recruitment status Closed to recruitment: follow up complete
Secondary Ids Issuing authority/Trial register Links to Secondary ID

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

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 Min age Max 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 Years 80 Years 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 2011/03/24 Medical Research Coordinating Comittee, Ministry of Health and Social Welfare, United Republic of Tanzania
Ethics Committee Address
Street address City Postal code Country
Dar es Salaam PO Box 9083 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 2011/04/12 Biomedical Research Ethics Committee, University of Zambia
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
University Teaching Hospital Nationalist Road Lusaka Zambia
Natinoal Institute for Medical Research Mwanza Tanzania

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
Paul Kelly Barts & The London School of Medicine, Turner St London E1 2AD United Kingdom
Suzanne Filteau LSHTM, Keppel Street London WC1E 7HT United Kingdom
Henrik Friis Institute of Nutrition, University of Copenhagen Copenhagen Denmark
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 Fax
Principal Investigator Prof Suzanne Filteau suzanne.filteau@lshtm.ac.uk +44 20 7958 8108
Street address City Postal code Country Position / Affiliation
London School of Hygiene & Tropical Medicine London WC1E 7HT United Kingdom Professor of International Nutrition
Role Name Email Phone Fax
Public Enquiries Ms Yolanda Fernandez Yolanda.Fernandez@ lshtm.ac.uk +44 20 7958 8108
Street address City Postal code Country Position / Affiliation
Keppel Street London WC1E 7HT United Kingdom Project Administrator
Role Name Email Phone Fax
Scientific Enquiries Prof Suzanne Filteau suzanne.filteau@lshtm.ac.uk +44 20 79588108
Street address City Postal code Country Position / Affiliation
LSHTM, Keppel St London WC1E 7HT United Kingdom