Condition category
Infections and Infestations
Date applied
13/06/2006
Date assigned
03/07/2006
Last edited
16/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.nida.nih.gov

Funders

Funder type

Government

Funder name

National Institute on Drug Abuse (USA)

Alternative name(s)

NIDA

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

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

Results - basic reporting

Publication summary

Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17242315

Publication citations

  1. 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.

Additional files

Editorial Notes