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ISRCTN
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ISRCTN22553118
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ClinicalTrials.gov identifier
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Public title
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Miami Selenium for heart & immune health trial
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Scientific title
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Acronym
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MIASEL
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Serial number at source
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RO1 DA13128
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Study hypothesis
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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.
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Ethics approval
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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.
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Study design
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Two group randomised double-blind placebo-controlled study
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Countries of recruitment
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USA
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Disease/condition/study domain
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Human Immunodeficiency Virus (HIV)
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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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
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Anticipated start date
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23/03/2001
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Anticipated end date
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30/06/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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280
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Interventions
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Selenium supplement (200 ug/day) versus placebo
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Primary outcome measure(s)
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HIV viral load, CD4 count, metabolic syndrome, cardiac contractility, cardiac compliance, cardiac mass
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Secondary outcome measure(s)
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Oxidative stress, inflammation
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Sources of funding
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National Institute on Drug Abuse (USA)
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Trial website
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Publications
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Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17242315
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Contact name
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Dr
Barry
Hurwitz
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Address
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Behavioral Medicine Reaserch Center (200 BMRC)
c/o VA Medical Center
1201 NW 16 Street
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City/town
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Miami
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Zip/Postcode
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33125
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Country
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United States of America
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Tel
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+1 305 575 7161
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Fax
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+1 305 575 7173
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Email
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bhurwitz@miami.edu
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Sponsor
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National Institute on Drug Abuse (USA)
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Address
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National Institutes of Health
6001 Executive Boulevard
Room 5213
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City/town
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Bethesda
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Zip/Postcode
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20892-9561
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Country
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United States of America
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Tel
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+1 301 443 1124
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Email
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webmaster@lists.nida.nih.gov
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Sponsor website:
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http://www.nida.nih.gov
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Date applied
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13/06/2006
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Last edited
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23/04/2007
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Date ISRCTN assigned
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03/07/2006
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