Condition category
Infections and Infestations
Date applied
24/01/2006
Date assigned
12/05/2006
Last edited
02/06/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

Additional files

Editorial Notes