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.
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
  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.
  
  
  CONCLUSIONS
  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.affiliation: Rwanda Selenium Supplementation Clinical Trial Team, Kigali, Rwanda.
authors.forename: Julius
authors.initials: J
authors.lastname: Kamwesiga
authors.forename: Vincent
authors.initials: V
authors.lastname: Mutabazi
authors.forename: Josephine
authors.initials: J
authors.lastname: Kayumba
authors.forename: Jean-Claude K
authors.initials: JC
authors.lastname: Tayari
authors.forename: Richard
authors.initials: R
authors.lastname: Smyth
authors.forename: Heather
authors.initials: H
authors.lastname: Fay
authors.forename: Alice
authors.initials: A
authors.lastname: Umurerwa
authors.forename: Marcel
authors.initials: M
authors.lastname: Baziruwiha
authors.forename: Christian
authors.initials: C
authors.lastname: Ntizimira
authors.forename: Antoinette
authors.initials: A
authors.lastname: Murebwayire
authors.forename: Jean Pierre
authors.initials: JP
authors.lastname: Haguma
authors.forename: Julienne
authors.initials: J
authors.lastname: Nyiransabimana
authors.forename: Donatille
authors.initials: D
authors.lastname: Habarurema
authors.forename: Veneranda
authors.initials: V
authors.lastname: Mukarukundo
authors.forename: Jean Bosco
authors.initials: JB
authors.lastname: Nzabandora
authors.forename: Pascal
authors.initials: P
authors.lastname: Nzamwita
authors.forename: Ernestine
authors.initials: E
authors.lastname: Mukazayire
authors.forename: Edward J
authors.initials: EJ
authors.lastname: Mills
authors.forename: Dugald
authors.initials: D
authors.lastname: Seely
authors.forename: Douglas J
authors.initials: DJ
authors.lastname: McCready
authors.forename: Don
authors.initials: D
authors.lastname: Warren
mesh_terms: D018791:CD4 Lymphocyte Count; D019587:Dietary Supplements; D015658:HIV Infections / Q000453:epidemiology / Q000276:immunology* / Q000523:psychology / Q000821:virology; D006801:Humans; D009017:Morbidity; D011788:Quality of Life; D012432:Rwanda; D012643:Selenium / Q000008:administration & dosage*
chemical_list: D012643:Selenium