Contact information
Type
Scientific
Primary contact
Dr Barry Hurwitz
ORCID ID
Contact details
Behavioral Medicine Reaserch Center (200 BMRC)
c/o VA Medical Center
1201 NW 16 Street
Miami
33125
United States of America
+1 305 575 7161
bhurwitz@miami.edu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RO1 DA13128
Study information
Scientific title
Acronym
MIASEL
Study hypothesis
The primary aim of this project is to examine whether selenium supplementation in cocaine-abusing and non-substance-abusing Human Immunodeficiency Virus (HIV) infected persons will diminish oxidative stress and improve immune function, insulin sensitivity, cardiac and vascular function, and indices of Cardiovascular Disease (CVD) risk. The secondary aim of this project is to determine whether oxidative stress, insulin sensitivity, and immune and cardiovascular function are potential mediating mechanisms for selenium effects on the measures of CVD risk.
Ethics approval
3/23/2001; 5/15/2002; 4/14/2003; 3/8/2004; 3/29/2005; 1/18/2006 WIRB PRNo:20060171
All dates except the last pertain to University of Miami Institutional Review Board. Due to institutional difficulties, the protocol was then outsourced by the University of Miami to the Western Institutional Review Board.
Study design
Two group randomised double-blind placebo-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Human Immunodeficiency Virus (HIV)
Intervention
Selenium supplement (200 ug/day) versus placebo
Intervention type
Drug
Phase
Not Specified
Drug names
Selenium
Primary outcome measure
HIV viral load, CD4 count, metabolic syndrome, cardiac contractility, cardiac compliance, cardiac mass
Secondary outcome measures
Oxidative stress, inflammation
Overall trial start date
23/03/2001
Overall trial end date
30/06/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Participants provided informed consent
2. Presented documented evidence of their HIV-1 infection
3. Were 18 to 55 years of age
4. Were not being treated pharmacologically for a diagnosed cardiovascular condition (e.g., beta-blockers, calcium antagonists, Angiotensin-Converting Enzyme [ACE] inhibitors), for carbohydrate conditions (e.g., hypoglycemics, insulin sensitizers), for psychiatric conditions (e.g., antipsychotics, antidepressives), and for endocrine conditions (e.g., estrogen hormonal replacement)
5. Presented no evidence of myocardial infarction or Atrio-Ventricular (AV) conduction arrhythmias upon electrocardiogram
6. Had no history of diabetes or cardiovascular disorder, or other major systemic diagnosis unrelated to HIV spectrum disease
7. Had no gross neurocognitive dysfunction indicated by a Folstein Mini-Mental Status Exam (MMSE) score < 26
8. Did not have a recent acute infection or surgery within three months of study entry
9. Were premenopausal and not pregnant with no intent to become pregnant
10. Were not participating in another blinded clinical trial
11. Refused to discontinue use of a nutritive supplement that contained > 50 ug per pill
12. Had a serum selenium level upon screen equal or superior to 75 ug/l.
Participants meeting these criteria signed an informed consent form for screening and if still eligible additional written consent was obtained for randomization into the trial.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
280
Participant exclusion criteria
1. Participating in another blinded clinical trial
2. Being treated pharmacologically (e.g., beta-blockers, calcium antagonists, ace inhibitors) for diagnosed cardiovascular function
3. Pregnant or have the intent to become pregnant
4. Post-menopausal women
5. Presenting an electrocardiogram (ECG) arrhythmia in which the proposed cardiovascular assessments would be contraindicated
6. Taking any medications that have contraindicating cardiovascular effects (i.e., tricyclic anti-depressant medications, etc.)
7. Displaying gross neurocognitive dysfunction indicated by a Folstein Mini-Mental Status Exam (MMSE) score equal or superior to 26
Recruitment start date
23/03/2001
Recruitment end date
30/06/2006
Locations
Countries of recruitment
United States of America
Trial participating centre
Behavioral Medicine Reaserch Center (200 BMRC)
Miami
33125
United States of America
Sponsor information
Organisation
National Institute on Drug Abuse (USA)
Sponsor details
National Institutes of Health
6001 Executive Boulevard
Room 5213
Bethesda
20892-9561
United States of America
+1 301 443 1124
webmaster@lists.nida.nih.gov
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Institute on Drug Abuse (USA)
Alternative name(s)
NIDA
Funding Body Type
government organisation
Funding Body Subtype
Research institutes and centers
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Publication citations
-
Results
Hurwitz BE, Klaus JR, Llabre MM, Gonzalez A, Lawrence PJ, Maher KJ, Greeson JM, Baum MK, Shor-Posner G, Skyler JS, Schneiderman N, Suppression of human immunodeficiency virus type 1 viral load with selenium supplementation: a randomized controlled trial., Arch. Intern. Med., 2007, 167, 2, 148-154, doi: 10.1001/archinte.167.2.148.