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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
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. ME...
Autores principales: | , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2011
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3182905/ https://www.ncbi.nlm.nih.gov/pubmed/21838913 http://dx.doi.org/10.1186/1745-6215-12-192 |
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author | Kamwesiga, Julius Mutabazi, Vincent Kayumba, Josephine Tayari, Jean-Claude K Smyth, Richard Fay, Heather Umurerwa, Alice Baziruwiha, Marcel Ntizimira, Christian Murebwayire, Antoinette Haguma, Jean Pierre Nyiransabimana, Julienne Habarurema, Donatille Mukarukundo, Veneranda Nzabandora, Jean Bosco Nzamwita, Pascal Mukazayire, Ernestine Mills, Edward J Seely, Dugald McCready, Douglas J Warren, Don |
author_facet | Kamwesiga, Julius Mutabazi, Vincent Kayumba, Josephine Tayari, Jean-Claude K Smyth, Richard Fay, Heather Umurerwa, Alice Baziruwiha, Marcel Ntizimira, Christian Murebwayire, Antoinette Haguma, Jean Pierre Nyiransabimana, Julienne Habarurema, Donatille Mukarukundo, Veneranda Nzabandora, Jean Bosco Nzamwita, Pascal Mukazayire, Ernestine Mills, Edward J Seely, Dugald McCready, Douglas J Warren, Don |
author_sort | Kamwesiga, Julius |
collection | PubMed |
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/mm(3), 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/mm(3) (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 |
format | Online Article Text |
id | pubmed-3182905 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2011 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-31829052011-09-30 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 Kamwesiga, Julius Mutabazi, Vincent Kayumba, Josephine Tayari, Jean-Claude K Smyth, Richard Fay, Heather Umurerwa, Alice Baziruwiha, Marcel Ntizimira, Christian Murebwayire, Antoinette Haguma, Jean Pierre Nyiransabimana, Julienne Habarurema, Donatille Mukarukundo, Veneranda Nzabandora, Jean Bosco Nzamwita, Pascal Mukazayire, Ernestine Mills, Edward J Seely, Dugald McCready, Douglas J Warren, Don Trials Study Protocol 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/mm(3), 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/mm(3) (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 BioMed Central 2011-08-13 /pmc/articles/PMC3182905/ /pubmed/21838913 http://dx.doi.org/10.1186/1745-6215-12-192 Text en Copyright ©2011 Kamwesiga et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Study Protocol Kamwesiga, Julius Mutabazi, Vincent Kayumba, Josephine Tayari, Jean-Claude K Smyth, Richard Fay, Heather Umurerwa, Alice Baziruwiha, Marcel Ntizimira, Christian Murebwayire, Antoinette Haguma, Jean Pierre Nyiransabimana, Julienne Habarurema, Donatille Mukarukundo, Veneranda Nzabandora, Jean Bosco Nzamwita, Pascal Mukazayire, Ernestine Mills, Edward J Seely, Dugald McCready, Douglas J Warren, Don 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3182905/ https://www.ncbi.nlm.nih.gov/pubmed/21838913 http://dx.doi.org/10.1186/1745-6215-12-192 |
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