Rwanda Selenium Supplementation Clinical Trial (RSST)
|ClinicalTrials.gov Identifier: NCT01327755|
Recruitment Status : Completed
First Posted : April 4, 2011
Last Update Posted : October 29, 2013
|Condition or disease||Intervention/treatment||Phase|
|HIV||Dietary Supplement: Selenium Other: Placebo||Phase 3|
Patients will be recruited from two health facilities (Kibagabaga District Hospital, and Kinyinya Health Center in Kigali), Rwanda that offer care and treatment for HIV/AIDS patients. Patients will be recruited during a 3-4 month period. Consenting adults who fit the inclusion criteria will be enrolled and followed for 2 years. Study assessments will occur at enrollment, 6, 12, 18, and 24 months after initiation of selenium supplementation.
Participants will be randomized using a simple randomized block design to receive either cotrimoxazole and selenium or cotrimoxazole and an identically appearing placebo taken once daily for 2 years. Participants who do not return to the clinic as scheduled will be followed up at home.
All consenting patients with CD4 count between 400 and 650 mm3 will be selected because they are at similar immunological level and hence they will not be eligible to start ARV treatment at the study start. The study will look at the efficacy of selenium supplementation to this already compromised group of patients at a similar stage of the disease.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Selenium Supplementation on CD4 + Cell Recovery, Viral Suppression, Morbidity and Quality of Life of HIV Infected Patients in Rwanda: a Prospective, Double-Blinded, Placebo-Controlled Trial|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
Dietary Supplement: Selenium
Selenium yeast containing selenomethionine 200 mcg per day for 2 years
|Placebo Comparator: Placebo||
Same number of pills, frequency, and duration as selenium intervention.
- CD4 count [ Time Frame: Baseline, 6, 12, 18, and 24 months ]
- viral load [ Time Frame: Baseline, 12, and 24 months ]
- Occurrence of opportunistic infections [ Time Frame: Baseline, 6, 12, 18, and 24 months ]
- Incidence of antiretroviral therapy (ART)initiation [ Time Frame: Baseline, 6, 12, 18, and 24 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01327755
|Kinyinya Health Center|
|Principal Investigator:||Julius K Kamwesiga, MD MPH(cand)||Rwanda Selenium Supplementation Clinical Trial|
|Principal Investigator:||Don Warren, BSc ND DHANP||Global Benefit Canada|