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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
Effect of selenium supplementation on CD4 T-cell recovery, viral suppression, morbidity and quality of life of HIV-infected patients in Rwanda: Study protocol for a randomized controlled trial
Trials, Volume 12, Article 192, Year 2011
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Description
Background: Low levels of serum selenium are associated with increased risk of mortality among HIV+ patients in East Africa. We aim to assess the effect of selenium supplementation on CD4 cell count, HIV viral load, opportunistic infections, and quality of life in HIV-infected patients in Rwanda.Methods and Design: A 24-month, multi-centre, patient and provider-blinded, randomized, placebo-controlled clinical trial involving 300 pre-antiretroviral therapy (ART) HIV-infected patients will be carried out at two sites in Rwanda. Patients ≥ 21 years of age with documented HIV infection, CD4 cell count of 400-650 cells/mm3, and not yet on ART will be recruited. Patients will be randomized at each study site using a randomized block design to receive either the selenium micronutrient supplement or an identically appearing placebo taken once daily. The primary outcome is a composite of time from baseline to reduction of CD4 T lymphocyte count below 350 cells/mm3 (confirmed by two measures at least one week apart), or start of ART, or the emergence of a documented CDC-defined AIDS-defining illness. An intention-to-treat analysis will be conducted using stepwise regression and structural equation modeling.Discussion: Micronutrient interventions that aim to improve CD4 cell count, decrease opportunistic infections, decrease HIV viral load, and ultimately delay initiation of more costly ART may be beneficial, particularly in resource-constrained settings, such as sub-Saharan Africa. Additional trials are needed to determine if micro-supplementation can delay the need for more costly ART among HIV-infected patients. If shown to be effective, selenium supplementation may be of public health importance to HIV-infected populations, particularly in sub-Saharan Africa and other resource-constrained settings.Trial Registration: NCT01327755. © 2011 Kamwesiga et al; licensee BioMed Central Ltd.
Authors & Co-Authors
Kamwesiga, Julius Tunga
Rwanda, Kigali
Rwanda Selenium Supplementation Clinical Trial Team
Mutabazi, Vincent
Rwanda, Kigali
Rwanda Selenium Supplementation Clinical Trial Team
Kayumba, Josephine
Rwanda, Kigali
Rwanda Selenium Supplementation Clinical Trial Team
Tayari, Jean Claude K.
Rwanda, Kigali
Rwanda Selenium Supplementation Clinical Trial Team
Smyth, Richard
Rwanda, Kigali
Rwanda Selenium Supplementation Clinical Trial Team
Fay, Heather
Rwanda, Kigali
Rwanda Selenium Supplementation Clinical Trial Team
Umurerwa, Alice
Rwanda, Kigali
Rwanda Selenium Supplementation Clinical Trial Team
Baziruwiha, Marcel
Rwanda, Kigali
Rwanda Selenium Supplementation Clinical Trial Team
Ntizimira, Christian Ruchaho
Rwanda, Kigali
Rwanda Selenium Supplementation Clinical Trial Team
Murebwayire, Antoinette
Rwanda, Kigali
Rwanda Selenium Supplementation Clinical Trial Team
Haguma, Jean Pierre
Rwanda, Kigali
Rwanda Selenium Supplementation Clinical Trial Team
Nyiransabimana, Julienne
Rwanda, Kigali
Rwanda Selenium Supplementation Clinical Trial Team
Habarurema, Donatille
Rwanda, Kigali
Rwanda Selenium Supplementation Clinical Trial Team
Mukarukundo, Veneranda
Rwanda, Kigali
Rwanda Selenium Supplementation Clinical Trial Team
Nzabandora, Jean Bosco
Rwanda, Kigali
Rwanda Selenium Supplementation Clinical Trial Team
Nzamwita, Pascal
Rwanda, Kigali
Rwanda Selenium Supplementation Clinical Trial Team
Mukazayire, Ernestine
Rwanda, Kigali
Rwanda Selenium Supplementation Clinical Trial Team
Mills, Edward J.
Canada, Ottawa
University of Ottawa
Seely, Dugald
Canada, Toronto
Canadian College of Naturopathic Medicine
McCready, Douglas J.
Canada, Waterloo
Lazaridis School of Business and Economics
Warren, Don
Rwanda, Kigali
Rwanda Selenium Supplementation Clinical Trial Team
Statistics
Citations: 21
Authors: 21
Affiliations: 4
Identifiers
Doi:
10.1186/1745-6215-12-192
e-ISSN:
17456215
Research Areas
Disability
Health System And Policy
Infectious Diseases
Study Approach
Quantitative
Study Locations
Multi-countries
Rwanda