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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
History of Changes
  Purpose
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.

Condition Intervention Phase
HIV
 Dietary Supplement: Selenium
Other: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by The Canadian College of Naturopathic Medicine:

Primary Outcome Measures:
  • CD4 count [ Time Frame: Baseline, 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]
Estimated Enrollment: 300
Study Start Date: February 2011
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Selenium Dietary Supplement: Selenium
Selenium yeast containing selenomethionine 200 mcg per day for 2 years
Placebo Comparator: Placebo Other: Placebo
Same number of pills, frequency, and duration as selenium intervention.

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01327755

Locations
Rwanda
Kibagabaga Hospital
Kigali, Rwanda
Kinyinya Health Center
Kigali, Rwanda
Sponsors and Collaborators
The Canadian College of Naturopathic Medicine
Global Benefit Canada
University of Ottawa
Wilfrid Laurier University
Kibagabaga District Hospital
Kinyinya Health Centre
Investigators
Principal Investigator: Julius K Kamwesiga, MD MPH(cand) Rwanda Selenium Supplementation Clinical Trial
Principal Investigator: Don Warren, BSc ND DHANP Global Benefit Canada
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: The Canadian College of Naturopathic Medicine
ClinicalTrials.gov Identifier: NCT01327755     History of Changes
Other Study ID Numbers: RCT-32122010 
Study First Received: January 11, 2011
Last Updated: October 28, 2013
Health Authority: Rwanda: The Rwanda National AIDS Control Commission (CNLS)
Rwands: Rwanda Ministry of Health

Keywords provided by The Canadian College of Naturopathic Medicine:
Selenium
HIV/ AIDS
CD4 counts
Antiretroviral therapy

Additional relevant MeSH terms:
Selenium
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
 Physiological Effects of Drugs
Trace Elements
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on September 27, 2016