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	https://doi.org/10.1186/ISRCTN67515515
Secondary identifying numbers	P.04/05/350

Submission date: 24/01/2006
Registration date: 12/05/2006
Last edited: 02/06/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Mark John Manary
Scientific

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

Email	manary@kids.wustl.edu

Study information

Study design	Randomized single-blind (investigator) controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Ready-to-use therapeutic food or corn-soy blend
Primary outcome measure	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 study start date	06/01/2006
Completion date	06/05/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	450 (2 groups of 225 each)
Key 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
Key exclusion criteria	1. Age <18 years 2. Pregnant or lactating women 3. Enrolment in any other supplementary feeding program
Date of first enrolment	06/01/2006
Date of final enrolment	06/05/2007

Locations

Countries of recruitment

Malawi
United States of America

Study participating centre

Washington University in St. Louis School of Medicine

Missouri
63110
United States of America

Sponsor information

St. Louis Children's Hospital (USA)
Hospital/treatment centre

Department of Pediatrics
Division of Emergency Medicine
St. Louis Children's Hospital
One Children's Place
St. Louis
Missouri
63110
United States of America

Email	manary@kids.wustl.edu
"ROR"	https://ror.org/00qw1qw03

Funders

Funder type

Charity

Academy for Educational Development, Washington DC (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	22/05/2009		Yes	No