Rwanda Selenium Supplementation Clinical Trial (RSST)

October 28, 2013 updated by: The Canadian College of Naturopathic Medicine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Rwanda
      • Kigali, Rwanda
        • Kibagabaga Hospital
      • Kigali, Rwanda
        • Kinyinya Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Same number of pills, frequency, and duration as selenium intervention.
Experimental: Selenium
Dietary supplement: Selenium
Selenium yeast containing selenomethionine 200 mcg per day for 2 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CD4 count
Time Frame: Baseline, 6, 12, 18, and 24 months
Baseline, 6, 12, 18, and 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
viral load
Time Frame: Baseline, 12, and 24 months
Baseline, 12, and 24 months
Occurrence of opportunistic infections
Time Frame: Baseline, 6, 12, 18, and 24 months
Baseline, 6, 12, 18, and 24 months
Incidence of antiretroviral therapy (ART)initiation
Time Frame: Baseline, 6, 12, 18, and 24 months
Baseline, 6, 12, 18, and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Canadian College of Naturopathic Medicine

Collaborators

University of Ottawa
Wilfrid Laurier University
Global Benefit Canada
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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

January 11, 2011

First Submitted That Met QC Criteria

April 1, 2011

First Posted (Estimate)

April 4, 2011

Study Record Updates

Last Update Posted (Estimate)

October 29, 2013

Last Update Submitted That Met QC Criteria

October 28, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCT-32122010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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