Condition category
Infections and Infestations
Date applied
13/07/2010
Date assigned
04/10/2010
Last edited
25/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.ku.dk/english/

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25134117
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24708645

Publication citations

  1. 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.

Additional files

Editorial Notes