Assessing the effect of vitamin D on the CD4 count and some blood indices in HIV patients
Design
Randomised with a parallel group design of 66 patients in intervention and control group by simple random sampling
Settings and conduct
The data collecting was performed at Varamin Behavioral Counseling Center.The information collecting method was conducted by interviewing and filling out the questionnaire. The last CD4 of these patients was measured during their periodic evaluation every 3 months. CBC tests were performed for all patients at the same time as their CD4 levels were measured. a Perl of 50,000 units of vitamin D3 was orally administered per month to patients in the intervention group. three and six months after the intervention, the questionnaire was again filled up for the complete research samples and the tests contained therein.
Participants/Inclusion and exclusion criteria
The inclusion criteria are include non-pregnant women and men who had HIV infection, age older than 18 years, intervals of at least 6 months since the start of the last regimen, not taking vitamin supplements at least three months before the start of the study, no diseases and acute problems preventing intervention by taking vitamin D3
Exclusion criteria are include modifying the antiretroviral therapy during the study, getting pregnancy in female patients, the absence of referral patients for monthly supplementation of vitamin D3, people with sarcoidosis, hyperparathyroidism, kidney disease and histoplasmosis
Intervention groups
Intervention group: People who in addition to receiving antiretroviral drug take a Perl of 50,000 units of vitamin D3 orally per month.
control group: People who only receive antiretroviral drug.
Main outcome variables
Increased levels of vitamin D3 in patients؛ Increased number of CD4 and other blood factors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180926041146N1
Registration date:2018-11-10, 1397/08/19
Registration timing:retrospective
Last update:2018-11-10, 1397/08/19
Update count:0
Registration date
2018-11-10, 1397/08/19
Registrant information
Name
Zohreh Haghighatdana
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3624 2937
Email address
haghighatz@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-06-20, 1395/03/31
Expected recruitment end date
2018-03-05, 1396/12/14
Actual recruitment start date
2016-06-20, 1395/03/31
Actual recruitment end date
2018-03-05, 1396/12/14
Trial completion date
2018-09-05, 1397/06/14
Scientific title
Assessing the effect of vitamin D on the CD4 count and some blood indices in Human Immunodeficiency Virus (HIV) patients
Public title
Effect of vitamin D on maintaining immunity level in HIV patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age older than 18 years
Non-pregnant women
Intervals of at least 6 months since the start of the last regimen
Not taking vitamin supplements at least three months before the start of the study
No diseases and acute problems preventing intervention by taking vitamin D3
Lack of psychological illnesses and willingness to cooperate in this research project
Exclusion criteria:
Modifying the antiretroviral therapy during the study
Getting pregnancy in female patients
The absence of referral patients for monthly supplementation of vitamin D3 even for one month
The occurrence of any illness or specific problem during the conduct of the research
People with sarcoidosis, hyperparathyroidism, kidney disease and histoplasmosis
Age
From 18 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
66
Actual sample size reached:
66
Randomization (investigator's opinion)
Randomized
Randomization description
At first, by simple random sampling, the names of all people met the inclusion criteria were listed in the list of registered individuals at the specialist offices of the counseling center. After examining their files, their phone numbers and addresses were extracted. They were contacted and if they were enrolled to the study, if they were willing to cooperate and participate. Individuals were randomly entered the intervention and control groups. In this way, the cards with numbers 1 and 2 were prepared; the code of one was related to intervention as compared to the code of two for control group. These cards were placed in a thick envelope, and patients in the first stage of sampling, when they went to each, chose a card, and they were placed in the corresponding group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid beheshti University of Medical Sciences
Street address
Next to Ayatollah Taleghani Hospital, Shahid Erabi Ave., Yeman Blvd., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2018-08-13, 1397/05/22
Ethics committee reference number
IR.SBMU.PHNS.REC.1397.36
Health conditions studied
1
Description of health condition studied
HIV
ICD-10 code
B23.2
ICD-10 code description
HIV disease resulting in haematological and immunological abnormalities, not elsewhere classified
Primary outcomes
1
Description
CD4 Cells Count
Timepoint
Before intervention, three and six months after intervention
Method of measurement
Blood Test
Secondary outcomes
1
Description
Complete Blood Count
Timepoint
Before intervention, three and six months after the intervention
Method of measurement
Blood Test
Intervention groups
1
Description
Intervention group: A Perl of 50,000 units of vitamin D3 was orally administered per month. Then, three and six months after the intervention, the questionnaire was again filled up for the complete research samples and the tests contained therein.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Varamin Behavioral Counseling Center
Full name of responsible person
Zohreh Haghighatdana
Street address
Shahid Beheshti Ave.
City
Varamin
Province
Tehran
Postal code
3371664339
Phone
+98 21 3624 4166
Fax
+98 21 3624 4166
Email
Haghighatz@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Hossein Hatami
Street address
Next to Ayatollah Taleghani Hospital, Shahid Erabi Ave., Yeman Blvd., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 2044
Email
haghighatz@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zohreh Haghighatdana
Position
MPH, MSc Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Next to the municipality, Shahid Beheshti Ave.
City
Varamin
Province
Tehran
Postal code
3371664339
Phone
+98 21 3624 2937
Fax
+98 21 3624 4166
Email
Haghighatz@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zohreh Haghighatdana
Position
MPH, MSc Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Next to the municipality, Shahid Beheshti Ave.
City
Varamin
Province
Tehran
Postal code
3371664339
Phone
+98 21 3624 2937
Fax
+98 21 3624 4166
Email
haghighatz@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zohreh Haghighatdana
Position
MPH, MSc Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Next to the municipality, Shahid Beheshti Ave.
City
Varamin
Province
Tehran
Postal code
3371664339
Phone
+98 21 3624 2937
Fax
+98 21 3624 4166
Email
haghighatz@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available