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Rwanda Selenium Supplementation Clinical Trial (RSST)

This study has been completed.
Sponsor:
Collaborators:
Global Benefit Canada
University of Ottawa
Wilfrid Laurier University
Kibagabaga District Hospital
Kinyinya Health Centre
Information provided by (Responsible Party):
The Canadian College of Naturopathic Medicine
ClinicalTrials.gov Identifier:
NCT01327755
First received: January 11, 2011
Last updated: October 28, 2013
Last verified: February 2013

January 11, 2011
October 28, 2013
February 2011
August 2013   (final data collection date for primary outcome measure)
CD4 count [ Time Frame: Baseline, 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01327755 on ClinicalTrials.gov Archive Site
  • viral load [ Time Frame: Baseline, 12, and 24 months ] [ Designated as safety issue: No ]
  • Occurrence of opportunistic infections [ Time Frame: Baseline, 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
  • Incidence of antiretroviral therapy (ART)initiation [ Time Frame: Baseline, 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Rwanda Selenium Supplementation Clinical Trial
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 Hypothesis: The addition of selenium supplementation to cotrimoxazole will improve CD4 counts, decrease opportunistic infections, decrease viral loads and delay the need for initiating antiretroviral therapy(ART) in Rwandan adult patients infected with HIV/ AIDS.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HIV
  • Dietary Supplement: Selenium
    Selenium yeast containing selenomethionine 200 mcg per day for 2 years
  • Other: Placebo
    Same number of pills, frequency, and duration as selenium intervention.
  • Experimental: Selenium
    Intervention: Dietary Supplement: Selenium
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Kamwesiga J, Mutabazi V, Kayumba J, Tayari JC, Smyth R, Fay H, Umurerwa A, Baziruwiha M, Ntizimira C, Murebwayire A, Haguma JP, Nyiransabimana J, Habarurema D, Mukarukundo V, Nzabandora JB, Nzamwita P, Mukazayire E, Mills EJ, Seely D, McCready DJ, Warren D. 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. 2011 Aug 13;12:192. doi: 10.1186/1745-6215-12-192.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
August 2013
August 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients > or = 21 years at enrollment
  • Confirmed HIV positive with a CD4 range between 400 and 650 mm3
  • HIV+ patients willing to participate in the study and who provide informed consent
  • Pre-antiretroviral therapy (Pre-ART) at enrollment in study (not yet initiated ART)
  • Willing to practice barrier method of birth control at all times

Exclusion Criteria:

  • Patients intending to be transferred out of the clinic catchment area before study ends
  • Patients scheduled to start ART
  • Moribund patients
  • Pregnant women
  • Unable or not wanting to commit to barrier method of birth control
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Rwanda
 
NCT01327755
RCT-32122010
No
The Canadian College of Naturopathic Medicine
The Canadian College of Naturopathic Medicine
  • Global Benefit Canada
  • University of Ottawa
  • Wilfrid Laurier University
  • Kibagabaga District Hospital
  • Kinyinya Health Centre
Principal Investigator: Julius K Kamwesiga, MD MPH(cand) Rwanda Selenium Supplementation Clinical Trial
Principal Investigator: Don Warren, BSc ND DHANP Global Benefit Canada
The Canadian College of Naturopathic Medicine
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP