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 Academic Article uri icon

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abstract

  • 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.

authors

  • 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 Joseph
  • Seely, Dugald
  • McCready, Douglas J
  • Warren, Don

publication date

  • December 2011