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Randomized controlled trial comparing the impact of supplementary feeding with either ready-to-use therapeutic food or corn-soy blend among malnourished anti-retroviral therapy clients in Malawi
ISRCTN ISRCTN67515515
DOI 10.1186/ISRCTN67515515
ClinicalTrials.gov identifier
EudraCT number
Public title Randomized controlled trial comparing the impact of supplementary feeding with either ready-to-use therapeutic food or corn-soy blend among malnourished anti-retroviral therapy clients in Malawi
Scientific title
Acronym N/A
Serial number at source P.04/05/350
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)
Lay summary
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
Countries of recruitment Malawi
Disease/condition/study domain Malnutrition and HIV infection
Participants - 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
Participants - exclusion criteria 1. Age <18 years
2. Pregnant or lactating women
3. Enrolment in any other supplementary feeding program
Anticipated start date 06/01/2006
Anticipated end date 06/05/2007
Status of trial Completed
Patient information material
Target number of participants 450 (2 groups of 225 each)
Interventions 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
Primary outcome measure(s) Body mass index and fat free body mass as measured by the bioelectrical impedance at 3, 6, 9 and 12 months
Secondary outcome measure(s) 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
Sources of funding Academy for Educational Development, Washington DC (USA)
Trial website
Publications 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19465470
Contact name Prof  Mark John  Manary
  Address 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
  City/town Missouri
  Zip/Postcode 63110
  Country United States of America
  Email manary@kids.wustl.edu
Sponsor St. Louis Children's Hospital (USA)
  Address Department of Pediatrics
Division of Emergency Medicine
St. Louis Children's Hospital
One Children's Place
St. Louis
  City/town Missouri
  Zip/Postcode 63110
  Country United States of America
  Email manary@kids.wustl.edu
Date applied 24/01/2006
Last edited 02/06/2009
Date ISRCTN assigned 12/05/2006
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