Contact information
Type
Scientific
Primary contact
Prof Mark John Manary
ORCID ID
Contact details
Washington University in St. Louis School of Medicine
Department of Pediatrics
Division of Emergency Medicine
St. Louis Children's Hospital
One Children's Place
St. Louis
Missouri
63110
United States of America
manary@kids.wustl.edu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
P.04/05/350
Study information
Scientific title
Acronym
Study hypothesis
Among wasted human immunodeficiency virus (HIV)-infected adults starting anti-retroviral therapy (ART), those that receive short-term, nutrient-dense ready-to-use therapeutic food (RUTF), may show an increase in body weight, experience fewer significant clinical events and higher CD4 counts, than their counterparts that receive corn-soy blend (CSB)
Ethics approval
University of Malawi College of Medicine Research Ethics Committee (COMREC), reference number: P.04/05/350; Federal Wide Assurance Number 00001395 and registration number 00001157. Also reviewed and approved by the Human Studies Committee, Washington University School of Medicine, St. Louis, Missouri.
Study design
Randomized single-blind (investigator) controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Malnutrition and HIV infection
Intervention
375 g CSB (300 g corn and 75 g soy flour fortified with vitamins and minerals), or 260 g peanut-based RUTF (26% dried skimmed milk, 27% sugar, 26% peanut paste, 20% vegetable oil, and 1.5% vitamins) and mineral premix per person per day during their first three months of ART
Intervention type
Drug
Phase
Not Specified
Drug names
Ready-to-use therapeutic food or corn-soy blend
Primary outcome measures
Body mass index and fat free body mass as measured by the bioelectrical impedance at 3, 6, 9 and 12 months
Secondary outcome measures
1. The number and severity of clinical events at 3, 6, 9 and 12 months
2. Monthly change in quality of life assessment
3. The change from baseline in the CD4 count at three months
4. Serum albumin and hematocrit at three months
5. Viral load at three months
6. Compliance with ART regimen
7. Cost-effectiveness of the two dietary regimens
Overall trial start date
06/01/2006
Overall trial end date
06/05/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Adults (>18 years old) diagnosed with acquired immune deficiency syndrome (AIDS) and meeting eligibility criteria for ART according to the National HIV treatment guidelines
2. World Health Organisation (WHO) stage III or IV or any WHO stage and a CD4 count <200 /mm^3 and beginning treatment with ART with a body mass index (BMI) of <18.5
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
450 (2 groups of 225 each)
Participant exclusion criteria
1. Age <18 years
2. Pregnant or lactating women
3. Enrolment in any other supplementary feeding program
Recruitment start date
06/01/2006
Recruitment end date
06/05/2007
Locations
Countries of recruitment
Malawi
Trial participating centre
Washington University in St. Louis School of Medicine
Missouri
63110
United States of America
Sponsor information
Organisation
St. Louis Children's Hospital (USA)
Sponsor details
Department of Pediatrics
Division of Emergency Medicine
St. Louis Children's Hospital
One Children's Place
St. Louis
Missouri
63110
United States of America
manary@kids.wustl.edu
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Academy for Educational Development, Washington DC (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19465470
Publication citations
-
Results
Ndekha MJ, van Oosterhout JJ, Zijlstra EE, Manary M, Saloojee H, Manary MJ, Supplementary feeding with either ready-to-use fortified spread or corn-soy blend in wasted adults starting antiretroviral therapy in Malawi: randomised, investigator blinded, controlled trial., BMJ, 2009, 338, b1867.