The objective of this randomized double blind trial is to investigate the effect of Selenium supplementation on the CD4+ lymphocyte cell count in HIV infected patients. In this study, 100 HIV Infected patients who meet eligibility criteria will be randomly assigned into intervention or control group. The patients in the intervention group will receive Selenium gluconate capsule, 200 µgr elemental, daily for 6 months but in the control group will receive placebo. CD4+ lymphocyte cell count, blood hemoglobin level, body mass index, rate of opportunistic infections, and serum level of Selenium will be measured and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904244380N2
Registration date:2010-07-15, 1389/04/24
Registration timing:prospective
Last update:
Update count:0
Registration date
2010-07-15, 1389/04/24
Registrant information
Name
Azar Haddadi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6671 6546
Email address
haddadiaz@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2011-06-20, 1390/03/30
Expected recruitment end date
2012-12-20, 1391/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effect of Selenium supplementation on CD4+ T lymphocyte count in HIV+ patients refered to Iranian HIV/AIDS Research Center (IRCHA)
Public title
Determining the effect of Selenium supplementation on CD4+ T lymphocyte count in HIV+ patients refered to Iranian HIV/AIDS Research Center (IRCHA)
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Age 18-60 years, Confirmed HIV-1 infection with western blot test, receiving HAART, CD4 between 200 and 350, signing informed consent Exclusion criteria: Pregnancy, any other supplementation than Selinium, history of hypersensitivity to Selenium, unwilling to cooperate, any plan to leave Tehran during the next 9 months after beginning of the study, History of chronic kidney diseases
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Tehran University of Medical Sciences and Health Services
Street address
Medical Ethics Building, 16th Azar avenue, Tehran,
City
Tehran
Postal code
Approval date
empty
Ethics committee reference number
404 /130 /ص/89
Health conditions studied
1
Description of health condition studied
HIV infection
ICD-10 code
B24
ICD-10 code description
Unspecified human immunodeficiency virus [HIV] disease
Primary outcomes
1
Description
CD4+ T cell count
Timepoint
Baseline, every 3 months up to the end of the study
Method of measurement
flowcytometry
Secondary outcomes
1
Description
serum Selenium level
Timepoint
Baseline and at the end of the study
Method of measurement
Atomic absorption spectrometry
2
Description
Body mass index
Timepoint
Baseline and at the end of the study
Method of measurement
weight(kg)/height(m)×height(m)
3
Description
Blood hemoglobin
Timepoint
Baseline and at the end of the study
Method of measurement
CBC test
4
Description
Rate of opportunistic infections
Timepoint
Every month during the study
Method of measurement
Medical history and physical examination
Intervention groups
1
Description
Selenium gluconate 200 μgr elemental capsule once daily for 6 months
Category
Treatment - Drugs
2
Description
Placebo capsule, with the same taste and color and size, once daily for 6 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranian HIV/AIDS Research Center (IRCHA)
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor For Research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Tehran University of Medical Sciences,
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor For Research, Tehran University of Medical Sciences