Effects of nutritional supplementation for HIV patients starting antiretroviral treatment: randomised controlled trial in EthiopiaBMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g3187 (Published 15 May 2014) Cite this as: BMJ 2014;348:g3187
- Mette F Olsen, research fellow1,
- Alemseged Abdissa, doctoral researcher2,
- Pernille Kæstel, associate professor1,
- Markos Tesfaye, doctoral researcher3,
- Daniel Yilma, doctoral researcher4,
- Tsinuel Girma, doctoral researcher5,
- Jonathan C K Wells, professor6,
- Christian Ritz, biostatistician, associate professor1,
- Christian Mølgaard, associate professor1,
- Kim F Michaelsen, professor1,
- Dilnesaw Zerfu, associate researcher7,
- Søren Brage, researcher8,
- Åse B Andersen, professor9,
- Henrik Friis, professor1
- 1Department of Nutrition, Exercise and Sports, University of Copenhagen, Rolighedsvej 30, 1958 Frederiksberg C, Denmark
- 2Department of Laboratory Sciences and Pathology, Jimma University, Jimma, Ethiopia
- 3Department of Psychiatry, College of Public Health and Medical Sciences, Jimma University, Jimma, Ethiopia
- 4Department of Internal Medicine, Jimma University Specialized Hospital, Jimma, Ethiopia
- 5Department of Paediatric and Child Health, Jimma University Specialized Hospital, Jimma, Ethiopia
- 6Childhood Nutrition Research Centre, UCL Institute of Child Health, London, UK
- 7Ethiopian Health and Nutrition Research Institute, Addis Ababa, Ethiopia
- 8MRC Epidemiology Unit, University of Cambridge, Cambridge, UK
- 9Department of Infectious Diseases, Odense University Hospital, Odense, Denmark
- Correspondence to: M F Olsen
- Accepted 21 April 2014
Objectives To determine the effects of lipid based nutritional supplements with either whey or soy protein in patients with HIV during the first three months of antiretroviral treatment (ART) and to explore effects of timing by comparing supplementation at the start of ART and after three months delay.
Design Randomised controlled trial.
Setting Three public ART facilities in Jimma, Oromia region, Ethiopia.
Participants Adults with HIV eligible for ART with body mass index (BMI) >16.
Intervention Daily supplementation with 200 g (4600 kJ) of supplement containing whey or soy during either the first three or the subsequent three months of ART.
Outcome measures Primary: lean body mass assessed with deuterium dilution, grip strength measured with dynamometers, and physical activity measured with accelerometer and heart rate monitors. Secondary: viral load and CD4 counts. Auxiliary: weight and CD3 and CD8 counts.
Results Of 318 patients enrolled, 210 (66%) were women, mean age was 33 (SD 9), and mean BMI was 19.5 (SD 2.4). At three months, participants receiving the supplements containing whey or soy had increased their lean body mass by 0.85 kg (95% confidence interval 0.16 kg to 1.53 kg) and 0.97 kg (0.29 kg to 1.64 kg), respectively, more than controls. This was accompanied by an increased gain of grip strength of 0.68 kg (−0.11 kg to 1.46 kg) for the whey supplement group and 0.93 kg (0.16 kg to 1.70 kg) for the soy supplement group. There were no effects on physical activity. Total weight gain increased by 2.05 kg (1.12 kg to 2.99 kg) and 2.06 kg (1.14 kg to 2.97 kg) for the whey and soy groups, respectively. In addition, in the whey supplement group overall CD3 counts improved by 150 cells/µL (24 to 275 cells/µL), of which 112 cells/µL (15 to 209 cells/µL) were CD8 and 25 cells/µL (−2 to 53 cells/µL) were CD4. Effects of the soy containing supplement on immune recovery were not significant. The effects of the two supplements, however, were not significantly different in direct comparison. Exploratory analysis showed that relatively more lean body mass was gained by patients with undetectable viral load at three months. Patients receiving delayed supplementation had higher weight gain but lower gains in functional outcomes.
Conclusions Lipid based nutritional supplements improved gain of weight, lean body mass, and grip strength in patients with HIV starting ART. Supplements containing whey were associated with improved immune recovery.
Trial registration Controlled-trials.com ISRCTN32453477.
We thank the participants, study team, and staff at the ART clinics at Jimma University Specialized Hospital, Jimma Health Centre, and Agaro Health Centre.
Contributors: MFO, AA, PK, CM, KFM, ABA, and HF conceptualised and designed the study. MFO, AA, PK, MT, DY, TG, DZ, and SB contributed to the acquisition of data. Data were analysed by MFO with the assistance of CR. MFO, AA, PK, JW, SB, ABA, and HF contributed to the interpretation of results. MFO drafted the manuscript, and all co-authors contributed to reviewing the manuscript. HF is guarantor.
Funding: The study was funded by US Dairy Export Council, International Atomic Energy Agency (IAEA), and Ministry of Foreign Affairs of Denmark (DANIDA). Nutriset developed the supplements and partially covered transportation expenses. The funders had no role in study design, data collection, and analysis, the decision to publish or preparation of the manuscript
Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.
Ethical approval: The study was approved by the Ethiopian National Health Research ethical review committee (RDHE/30-90/2009), and trial authorisation was obtained from the Food, Medicine and Health Care Administration and Control Authority of Ethiopia (02/6/05/50), while a consultative approval was given by the Danish national committee on biomedical research ethics. Written informed consent was obtained from all participants. Study visits were coordinated with routine visits for ART care and transportation costs were reimbursed for additional visits. A data safety and monitoring board assessed interim reports during the trial.
Data sharing: Additional data available on request from the corresponding author.
Transparency: The lead authors (MRO and AA) affirm that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.
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