Lack of benefit with omega-3 fatty acid supplementation in HIV patients: A randomized pilot study

Abstract

Objective: To assess the effect of omega-3 polyunsaturated fatty acids (n-3 PUFA) supplementation on bone metabolism in HIV-infected patients presenting with hypertriglyceridemia.

Methods: Patients were randomized 1:1 to receive 2 g of n-3 PUFA or fenofibrate (FF). The primary endpoint was % change in bone mineral density (BMD) from baseline to month 24 in lumbar spine (LS) and femoral neck (FN). Secondary endpoints were changes in Z-score, calcitriol, calcitonin, parathyroid hormone, osteocalcin, and C-terminal telopeptide of type I collagen (CTX-I) at 12 and 24 months. Differences in continuous variables were evaluated using the t test or Mann-Whitney U-test for independent samples and differences in means of intra- and inter-subject continuous variables using a general linear model. Categorical variables were compared by the chi-squared or Fisher’s exact test.

Results: 30 patients were included in each arm; 23 in the n-3 PUFA arm and 22 in the FF arm completed follow-up. No significant differences between arms were observed after 24 months in either region (FN: −12.51% ± 7.89 in the n-3 PUFA arm and -8.18% ± 7.72 in the FF arm, p = .07; LS: 2.94% ± 6.63 in the n-3 PUFA arm, −3.07% ± 16.85 in the FF arm, p = .07), although the BMD reduction in the FN region after 24 months was noticeable in both arms (n-3 PUFA: −12.51% ± 7.89%, p =< .001; FF: −8.183% ± 7.72%, p =< .001). There was a significant difference in calcitriol changes between arms after 96 weeks. No differences in Z-score or bone turnover markers were observed between the two arms.

Conclusions: Omega-3 fatty acid supplementation resulted in no beneficial changes in BMD or bone turnover markers. n-3 PUFA supplementation achieved similar reductions in triglyceride levels as FF.

Keywords:

• HIV
• Osteoporosis
• PUFA-3

Acknowledgments

We thank the CERCA Program of the Generalitat de Catalunya for institutional support. We also thank the Instituto de Salud Carlos III for funding this study. We dedicate this paper to our colleague and friend Elena Ferrer, MD, who has recently passed away. She largely contributed to the design and implementation of this study. Thanks, Helen, for all your important contributions to our HIV Unit over more than two decades. We will greatly miss you.

Additional information

Notes on contributors

Antonio Navarro-Alcaraz

Antonio Navarro-Alcaraz MSc, He obtained a Nutrition and Dietetics Degree from the University of Barcelona, Spain in 2009 and a MSc degree in Nutrition and Metabolism by the University of Barcelona, Spain in 2011. His clinical practice and research areas include cardiovascular disease, bone metabolism, lipodystrophy and gut microbiota alterations. He is working at the HIV and STD Unit, Bellvitge University Hospital since 2009.

Juan Tiraboschi

Dr Juan Manuel Tiraboschi He obtained a Medical Degree from the National University of Córdoba, Argentina in 1999. He trained in Medicine and Infectious Diseases in Argentina and France (2000–2007). He obtained a PhD degree in 2015 by the University of Barcelona investigating on “Penetration and antiviral activity of antiretroviral drugs in the Central Nervous System”. Between 2013 and 2016, Dr. Tiraboschi completed a fellowship as Clinical Research Doctor in HIV at St Thomas Hospital in London, UK. He joined the HIV and STD Unid at Bellvitge University Hospital in 2016. His clinical and research interests include the effects of HIV and antiretroviral therapy on Central Nervous System and viral reservoirs.

Carmen Gómez

Dr Carmen Gómez She obtained a Medical Degree from the University of Barcelona, Spain in 1991. She completed her Reumathology Medical training in The Hospital Universitari de Bellvitge (1991–1995). She obtained a PhD degree in 2000 by the University of Barcelona.

Beatriz Candas-Estébanez

Dr Beatriz Candas-Estébanez Specialist in Clinical Biochemistry (Hospital Universitari de Bellvitge, 2010). PhD by the University of Barcelona in the Human Molecular Genetics Program with Cum laude qualification (2011). Between 2011 and 2013 associate biochemistry in Servei Laboratori UDIAT of the Sanitary Corporation of the Parc Taulí Hospital (Sabadell) in Core of Biochemistry and serology and genetics of hepatitis. From 2013-present, associate biochemistry in Servei Laboratori Hospital de Bellvitge in the area of special biochemistry and molecular biology responsible for the biochemical aspects related to hormonal biochemistry and fertility. Director of 3 doctoral theses in progress, one of which ends in 2020. Member of the commission of lipidology and cardiovascular risk of the Spanish Society of Laboratory Medicine and the Commission of genetics of the Catalan Association of Clinical Laboratory Sciences. Author of more than 15 scientific publications of national and international scope. Awarded for the best communication in congress of national scope in 2 occasions (first author) and in other three (collaborating author or director of the work). Principal investigator in three calls for competitive public bodies (two completed and one in progress), and collaborator of another of the FIS Carlos III.

María Saumoy

Dr María Saumoy I completed Specialized Medical Training in Internal Medicine in 2003. Since then I have been combining the hospital care task with research in the field of HIV infection. In 2004, through a contract from the Instituto de Salud Carlos III, a post-MIR study carried out at Joan XXIII Hospital in Tarragona, I carried out research on the pathogenesis of metabolic complications related to antiretroviral treatment and the genetic role of these complications. I completed this line of research with a stay at the Institute of Microbiology of Lausanne, with the team of Dr. Amalio Telente. These studies allowed me to elaborate my doctoral thesis. In 2007 I joined the HIV Unit of the Infectious Diseases Service of the Hospital Universitario de Bellvitge where I have continued to this day. I have combined the care activity, basically to patients with HIV infection, with the research. Within the research I have participated in multiple randomized studies of antiretroviral drugs both nationally and internationally. On the other hand, I participated in studies promoted from our Unit with a line of research focused on the study of the pathogenesis of metabolic alterations related to HIV infection and antiretroviral treatment, as well as a study of cardiovascular risk associated with HIV. Some of these studies have been funded by competitive calls from public and private administrations. The result of these studies are the publications in which I appear as the first signer. For the past year, I have been consulting on Sexually Transmitted Diseases and Screening for Anal Cancer, in which we also carry out a research task.

Arkaitz Imaz

Dr Arkaitz Imaz received his MD from University of Navarra in 2002 and completed his Internal Medicine training at Vall d'Hebron Hospital (Barcelona) between 2003 and 2008. In 2010 he joined the Department of Infectious Diseases of Bellvitge University Hospital where he works as a physician in the HIV and STI Unit. Since 2008 he has been involved in clinical research in the field of HIV infections participating in research projects and clinical trials. He obtained his PhD from the Autonomous University of Barcelona in 2012. His main areas of interest are penetration, pharmacokinetics and activity of antiretroviral drugs in reservoirs (especially genital tract), drug-resistance and salvage therapy, sexually transmitted infections and HCV co-infection.

Daniel Podzamczer

Dr Daniel Podzamczer He qualified from the University of Buenos Aires and undertook training in Internal Medicine at Bellvitge University Hospital (Barcelona, Spain). He obtained a PhD degree in 1991 investigating on “predictors of progression to AIDS” (University of Barcelona, Spain). He started to see HIV-infected patients in the first years of the epidemic, that is in the mid of 80'. Thus he has lived very different periods in the history of AIDS. Beginning when AIDS was a fatal disease and patients died every day until now when HIV has become a chronic disease with a prolonged survival and an excellent life quality of patients receiving antiretroviral therapy. He is currently the head of an HIV and STD Unit within an Infectious Disease Service in a University teaching hospital in Barcelona. In his position he has contributed to clinical research, participating and organizing clinical trials related to opportunistic infections, HIV complications and antiretroviral therapy. He is a co-author of more than 250 scientific papers published in national and international Journals such as New Engl. J Med, Lancet, Ann Intern Med, Clin. Infect Dis., J Infect Dis., AIDS and JAIDS among others. He has also participated in expert panels for Guidelines for the management of opportunistic infections (NIH/CDC/IDSA), antiretroviral therapy, opportunistic infections and neurocognitive disorders (GESIDA). He is also a peer reviewer for a number of international Journals.