Miami Selenium for heart & immune health trial

ISRCTN	ISRCTN22553118
DOI	https://doi.org/10.1186/ISRCTN22553118
Secondary identifying numbers	RO1 DA13128

Submission date: 13/06/2006
Registration date: 03/07/2006
Last edited: 16/08/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Barry Hurwitz
Scientific

Behavioral Medicine Reaserch Center (200 BMRC)
c/o VA Medical Center
1201 NW 16 Street
Miami
33125
United States of America

Phone	+1 305 575 7161
Email	bhurwitz@miami.edu

Study information

Study design	Two group randomised double-blind placebo-controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	MIASEL
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	Human Immunodeficiency Virus (HIV)
Intervention	Selenium supplement (200 ug/day) versus placebo
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Selenium
Primary outcome measure	HIV viral load, CD4 count, metabolic syndrome, cardiac contractility, cardiac compliance, cardiac mass
Secondary outcome measures	Oxidative stress, inflammation
Overall study start date	23/03/2001
Completion date	30/06/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	280
Key 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.
Key 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
Date of first enrolment	23/03/2001
Date of final enrolment	30/06/2006

Locations

Countries of recruitment

United States of America

Study participating centre

Behavioral Medicine Reaserch Center (200 BMRC)

Miami
33125
United States of America

Sponsor information

National Institute on Drug Abuse (USA)
Government

National Institutes of Health
6001 Executive Boulevard
Room 5213
Bethesda
20892-9561
United States of America

Phone	+1 301 443 1124
Email	webmaster@lists.nida.nih.gov
Website	http://www.nida.nih.gov
"ROR"	https://ror.org/00fq5cm18

Funders

Funder type

Government

National Institute on Drug Abuse (USA)
Government organisation / National government

Alternative name(s): Instituto Nacional sobre el Abuso de Drogas de Estados Unidos, Instituto Nacional sobre el Abuso de Drogas, NIDA
Location: United States of America

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	22/01/2007		Yes	No