Plain English Summary
Background and study aims
HIV infection can make it difficult for the body to absorb nutrients properly and the diet of a HIV patient with poor access to food will often be grossly inadequate. It is likely that the weight loss during disease is largely due to loss of lean body mass (muscle and organ tissues), but weight gain during recovery and after initiation of medical HIV treatment (ART) is mainly due to accumulation of fat. This is likely to have a negative impact on the health and survival of the HIV infected patient, particularly when quality of the diet is poor. It is possible that milk components as part of nutritional support could improve weight gain, growth, and recovery from malnutrition, but this needs to be confirmed. However, it is not clear whether nutritional support would work best and be safest when given from the beginning of ART, or whether it should be delayed until the acute stage of the infection and the side effects accompanying initiation of ART (such as anorexia and reduced absorption of nutrients) have declined. The aim of this study is to look at the effect of a whey-containing nutritional supplement on adult HIV patients starting ART in Jimma, Ethiopia. The protein source in the supplement will be either whey or soy. All participants will receive a peanut-based food supplement covering half of their daily energy need for three months. Since the optimal timing of nutritional support is unknown, patients who are not severely malnourished will receive the supplement either in the first three or the subsequent three months on ART.
Who can participate?
The study will be conducted among 350 HIV patients. Adults (≥18 years) initiating ART can participate in the study. Severely wasted individuals (body mass index<16 kg/m2) are excluded and referred for routine treatment for severe acute malnutrition at the hospital.
What does the study involve?
Patients are invited to take a peanut butter-based nutrient supplement daily for three months either during the first three or the subsequent three months upon initiation of ART. The supplement will have either whey or soy as the main protein source. Participants will be randomly selected to receive their 3 month supply of supplement either immediately, or after a three month delay. Each participant will be examined monthly during the first 6 months, followed by a final examination 12 months after starting ART. The supplement is distributed from the research clinic at each monthly visit. Quality of life will be assessed and compared between the treatment groups using a questionnaire tool developed by the World Health Organisation (WHO) adapted to local context. Body composition will be assessed at the beginning of the trial and after 3 and 6 months. Grip strength will be measured, and physical activity will be assessed using the ActiHeart, a small combined accelerometer and heart rate monitor. Finally, blood samples will be taken from participants.
What are the possible benefits and risks of participating?
All patients will benefit from three months of daily supplementation with a high energy dietary supplement with high quality proteins of different origin. There are no known risks of the supplement. As the patients have HIV, they are already at high risk of disease and death, but the supplements are not expected to increase these risks.
Where is the study run from?
Jimma University Hospital, Ethiopia.
When is the study starting and how long is it expected to run for?
Recruitment began in July 2010 and ended in August 2012. Each participant is in the study for 12 months. The last 12-month follow-up visit will be conducted in August 2013.
Who is funding the study?
US Dairy export council (USDEC) and Danish International Development Agency (DANIDA)
Who is the main contact?
Dr Pernille Kæstel
pern@life.ku.dk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Kim Fleischer Michaelsen
ORCID ID
Contact details
University of Copenhagen
Department of Human Nutrition
Rolighedsvej 30
Frederiksberg C
1958
Denmark
-
kfm@life.ku.dk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The role of nutritional support of human immunodeficiency virus (HIV) infected patients on antiretroviral treatment: a randomised trial in Jimma, Ethiopia
Acronym
ARTFOOD
Study hypothesis
Ready-to-use supplementary foods (RUSF) given to human immunodeficiency virus (HIV) patients during the first three months of antiretroviral therapy (ART) increases lean body mass and physical performance, and the effect is larger if the supplement contains whey protein rather than soy.
On 10/01/2013 the following changes were made to the record:
1. The target number of participants was updated from 400 to 350.
2. The overall trial end date was updated from 31/12/2011 to 30/08/2013.
Ethics approval
1. Ethiopia: National Health Research Ethics Review Committee, 09/12/2009, ref: RDHE/30-90/2009
2. Denmark: Danish National Committee on Biomedical Research Ethics, 16/01/2009, ref: 2008-7041-137/sumih
Study design
Randomised single-blind nutritional supplementation trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Human immunodeficiency virus (HIV) infection
Intervention
200 g per day of a RUSF containing whey or soy protein for three months from the start of ART, or no supplement for the first three months, but the same supplement from three to six months after the start of ART.
Total duration of treatment: 3 months
Total duration of follow-up: 12 months
Intervention type
Supplement
Phase
Drug names
Primary outcome measure
Change over the first three months in:
1. Lean body mass as assessed using deuterium dilution test
2. Grip strength as assessed using a dynamometer
3. Physical activity assessed using a combined accelerometer and heart rate monitor
Secondary outcome measures
Measured after three months:
1. ART drug levels
2. HIV load and CD4 counts
3. Adherence to ART and quality of life
4. IGF-1
Overall trial start date
19/07/2010
Overall trial end date
30/08/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. HIV-infected adults (aged greater than or equal to 18 years, either sex) commencing ART
2. Living within approximately 50 km from Jimma
3. Consenting to participate
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
400
Participant exclusion criteria
1. Pregnant or lactating
2. Terminally ill from HIV or other serious condition
3. Patients who may not be able to consume RUSF due to extensive oral lesion
4. Patients with nutritional oedema
Recruitment start date
19/07/2010
Recruitment end date
30/08/2012
Locations
Countries of recruitment
Ethiopia
Trial participating centre
University of Copenhagen
Frederiksberg C
1958
Denmark
Sponsor information
Organisation
University of Copenhagen (Denmark)
Sponsor details
Department of Human Nutrition
Rolighedsvej 30
Frederiksberg
1958
Denmark
-
hfr@life.ku.dk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
US Dairy Export Council (USDEC) (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Danida (Denmark)
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
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25134117
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24708645
Publication citations
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Results
Olsen MF, Abdissa A, Kæstel P, Tesfaye M, Yilma D, Girma T, Wells JC, Ritz C, Mølgaard C, Michaelsen KF, Zerfu D, Brage S, Andersen AB, Friis H, Effects of nutritional supplementation for HIV patients starting antiretroviral treatment: randomised controlled trial in Ethiopia., BMJ, 2014, 348, g3187.