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Miami Selenium for heart & immune health trial
ISRCTN ISRCTN22553118
DOI 10.1186/ISRCTN22553118
ClinicalTrials.gov identifier
EudraCT number
Public title Miami Selenium for heart & immune health trial
Scientific title
Acronym MIASEL
Serial number at source RO1 DA13128
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.
Lay summary Not provided at time of registration
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
Countries of recruitment United States of America
Disease/condition/study domain Human Immunodeficiency Virus (HIV)
Participants - 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.
Participants - 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
Anticipated start date 23/03/2001
Anticipated end date 30/06/2006
Status of trial Completed
Patient information material
Target number of participants 280
Interventions Selenium supplement (200 ug/day) versus placebo
Primary outcome measure(s) HIV viral load, CD4 count, metabolic syndrome, cardiac contractility, cardiac compliance, cardiac mass
Secondary outcome measure(s) Oxidative stress, inflammation
Sources of funding National Institute on Drug Abuse (USA)
Trial website
Publications Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17242315
Contact name Dr  Barry  Hurwitz
  Address Behavioral Medicine Reaserch Center (200 BMRC)
c/o VA Medical Center
1201 NW 16 Street
  City/town Miami
  Zip/Postcode 33125
  Country United States of America
  Tel +1 305 575 7161
  Fax +1 305 575 7173
  Email bhurwitz@miami.edu
Sponsor National Institute on Drug Abuse (USA)
  Address National Institutes of Health
6001 Executive Boulevard
Room 5213
  City/town Bethesda
  Zip/Postcode 20892-9561
  Country United States of America
  Tel +1 301 443 1124
  Email webmaster@lists.nida.nih.gov
  Sponsor website: http://www.nida.nih.gov
Date applied 13/06/2006
Last edited 16/08/2011
Date ISRCTN assigned 03/07/2006
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