1. Home
  2. Approved trials
  3. » فارسی

The effect of zinc supplementation on CD4+ lymphocyte cell count in HIV patients in Iranian research center: a randomized double blind controlled trial

Protocol summary

Summary
The objective of this randomized double blind trial is to investigate the effect of Zinc 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 Zinc sulfate, 220 mg capsule (50 mg elemental zinc), 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 zinc will be measured and compared between groups. ‌

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138904244380N1
Registration date:
Registration timing: na

Last update:
Update count: 0
Registration date
empty
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
The effect of zinc supplementation on CD4+ lymphocyte cell count in HIV patients in Iranian research center: a randomized double blind controlled trial
Public title
The effect of zinc supplementation on CD4+ lymphocyte cell count in HIV patients in Iranian research center: a randomized double blind controlled trial
Purpose
Treatment
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 zinc, history of hypersensitivity to Zinc, 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
0
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
Street address
Medical Ethics Building, 16th Azar avenue, Tehran,
City
Tehran
Postal code
Approval date
2010-06-10, 1389/03/20
Ethics committee reference number
130/403/ص/89

Health conditions studied

1

Description of health condition studied
HIV infection
ICD-10 code
B24
ICD-10 code description
Unspecifidied immunodeficiency virus [hiv]disease

Primary outcomes

1

Description
CD4+ lymphocyte cell count
Timepoint
Baseline, every 3 months up to the end of the study
Method of measurement
Flowcytometry

Secondary outcomes

1

Description
Body mass index
Timepoint
Baseline and at the end of the study
Method of measurement
weight(kg)/height(m)×height(m)

2

Description
Blood hemoglobin
Timepoint
Baseline and at the end of the study
Method of measurement
CBC TEST

3

Description
Rate of opportunistic infections
Timepoint
Every month during the study
Method of measurement
Medical history and physical examination

4

Description
Serum level of zinc
Timepoint
Baseline and at the end of the study
Method of measurement
atomic absorption spectrometry

Intervention groups

1

Description
Control group: Placebo capsule (the same in taste and colour to zinc capsule) once daily during 6 months study intrvention
Category
Placebo

2

Description
Intevention group: Zinc sulphate 220 mg capsule contains 50 mg elemental zinc once daily during 6 months study
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Iranian AIDS Reasearch center
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 Fotuhi
Street address
Tehran University of Medical Sciences, Tehran, Iran
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
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran university of medical science,medical school
Full name of responsible person
Behnaz Edalatnoor
Position
Medical Student
Other areas of specialty/work
Street address
medical school, Tehran university of medical science,
City
Tehran
Postal code
Phone
+98 21 8474 2236
Fax
Email
edalatnoor.behnaz@ymail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran university of medical science,medical school
Full name of responsible person
Dr Azar Haddadi
Position
Infectious diseases Associate Professor
Other areas of specialty/work
Street address
Deputy of Research, Sina hospital, Hasanabad square, Imam Khomeini avenue
City
Tehran
Postal code
Phone
+98 21 6671 6545
Fax
Email
haddadiaz@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran university of medical science,medical school
Full name of responsible person
Behnaz Edalatnoor
Position
Medical Student
Other areas of specialty/work
Street address
Medical school, Tehran university of medical science,
City
Tehran
Postal code
Phone
+98 21 8474 2236
Fax
Email
edalatnoor.behnaz@ymail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...