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HIV Clin Trials. 2018 Jun;19(3):101-111. doi: 10.1080/15284336.2018.1459344. Epub 2018 Apr 17.

Design of a randomized controlled trial of zinc supplementation to improve markers of mortality and HIV disease progression in HIV-positive drinkers in St. Petersburg, Russia.

Author information

1
a Department of Medicine, Section of General Internal Medicine , Boston Medical Center, Clinical Addiction Research and Education (CARE) Unit , Boston , MA , USA.
2
b Vanderbilt Center for Clinical Cardiovascular Trials Evaluation (V-C3REATE) , Vanderbilt University Medical Center , Nashville , TN , USA.
3
c First Pavlov State Medical University of St. Petersburg , St. Petersburg , Russian Federation.
4
d Department of Biostatistics , Boston University School of Public Health , Boston , MA , USA.
5
e Data Coordinating Center , Boston University School of Public Health , Boston , MA , USA.
6
f Research Institute of Influenza , St. Petersburg , Russian Federation.
7
g Department of Medicine, Division of General Internal Medicine , University of Pittsburgh , Pittsburgh , PA , USA.
8
h St. Petersburg Bekhterev Research Psychoneurological Institute , St. Petersburg , Russian Federation.
9
i Department of Medicine, Section of General Internal Medicine, School of Medicine/Boston Medical Center, Clinical Addiction Research and Education (CARE) Unit , Boston University , Boston , MA , USA.
10
j Department of Community Health Sciences , Boston University School of Public Health , Boston , MA , USA.

Abstract

Background Russia continues to have an uncontrolled HIV epidemic and its per capita alcohol consumption is among the highest in the world. Alcohol use among HIV-positive individuals is common and is associated with worse clinical outcomes. Alcohol use and HIV each lead to microbial translocation, which in turn results in inflammation. Zinc supplementation holds potential for lowering levels of biomarkers of inflammation, possibly as a consequence of its impact on intestinal permeability. This paper describes the protocol of a double-blinded randomized placebo-controlled trial of zinc supplementation in St. Petersburg, Russia. Methods Participants (n = 254) were recruited between October 2013 and June 2015 from HIV and addiction clinical care sites, and non-clinical sites in St. Petersburg, Russia. Participants were randomly assigned, to receive either zinc (15 mg for men; 12 mg for women) or placebo, daily for 18 months. The following outcomes were assessed at 6, 12, and 18 months: (1) mortality risk (primary outcome at 18 months); (2) HIV disease progression; (3) cardiovascular risk; and (4) microbial translocation and inflammation. Adherence was assessed using direct (riboflavin) and indirect (pill count, self-report) measures. Conclusion Given the limited effectiveness of current interventions to reduce alcohol use, zinc supplementation merits testing as a simple, low-cost intervention to mitigate the consequences of alcohol use in HIV-positive persons despite ongoing drinking.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01934803.

KEYWORDS:

HIV; Russia; alcohol use; cardiovascular risk; inflammation; mortality risk; zinc

PMID:
29663871
PMCID:
PMC5957784
DOI:
10.1080/15284336.2018.1459344
[Indexed for MEDLINE]
Free PMC Article

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