This is a randomized, double-blind, placebo-controlled clinical trial aimed to investigate the effect of dehydroepiandrosterone (DHEA) on quality of life and disease activity in 46 women with rheumatoid arthritis. Inclusion criteria are pre-menopause women, having a definitive diagnosis of rheumatoid arthritis and a normal BMI and exclusion criteria are having other chronic diseases, hyperlipidemia and using anti-depressants. After inclusion in the study, in all patients, disease activity will be assessed using DAS-28 score and also quality of life will be evaluated using WHO questionnaire. Then, the patients will be randomly assigned into two equal groups; DHEA group who will receive the drug as 50 mg oral tablets once a day for three months and the placebo group who will receive placebo. At the end of the treatment period, the disease activity and quality of life will be evaluated again and the data
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017052134062N1
Registration date:2017-07-23, 1396/05/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-23, 1396/05/01
Registrant information
Name
Elnaz Langarizadeh
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5725
Email address
e.langarizadeh@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of DHEA (dehydroepiandrosterone) on quality of life and disease activity in women with Rheumatoid Arthritis
Public title
The effect of dehydroepiandrosterone on quality of life
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: pre-menopause women; having a definitive diagnosis of rheumatoid arthritis; having a normal BMI. Exclusion criteria: having other chronic diseases; hyperlipidemia; using anti-depressants.
Age
From 45 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization and blinding: Firstly, the resident will select 46 patients based on inclusion and exclusion criteria and introduce them to an educated nurse. The nurse will randomly, by using permuted block randomization, assign the patients into DHEA and placebo groups and register their names and the allocated group and then will write the names of patients of DHEA group on the DHEA drugs boxes and the names of patients of placebo group on the placebo boxes and will give the boxes to the resident to deliver the boxes to the patients; therefore, the resident is blinded (DHEA drugs and placebo boxes have a similar appearance). Considering that the boxes have a similar appearance, the patients are also blinded ( When giving a written consent, it will be explained to the patients that for improving the accuracy of the results, the patients should be blinded but they are either in DHEA or placebo group. The cons and pros of each treatment option will be explained).
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Postal code
Approval date
2017-04-16, 1396/01/27
Ethics committee reference number
IR.ZAUMS.REC.1396. 7
Health conditions studied
1
Description of health condition studied
rheumatoid arthritis
ICD-10 code
M05
ICD-10 code description
Seropositive rheumatoid arthritis
Primary outcomes
1
Description
Disease activity
Timepoint
Before study, at the en of the study
Method of measurement
Using DAS-28 score
2
Description
Quality of life
Timepoint
Before study, at the en of the study
Method of measurement
Using WHO questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
DHEA group: 50 mg oral tablets once a day for three months
Category
Treatment - Drugs
2
Description
Placebo group: daily oral tablets containing starch for thee months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ebne Abi Taleb Hospital
Full name of responsible person
Elnaz Langarizadeh
Street address
Khalije Fars Blv, Zahedan
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Zahedan University of Medical Sciences
Full name of responsible person
Hoshang Rafighdoost
Street address
Vice chancellor for research, Zahedan University of Medical Sciences campus, Jannat Blv, Zahedan
City
Zahedan
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, Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Elnaz Langarizadeh
Position
Internal medicine resident
Other areas of specialty/work
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Postal code
Phone
+98 54 3322 5715
Fax
+98 54 3322 5715
Email
e.langarizadeh@zaums.ac.ir, ayubabedi48@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mahnaz Sandooghi
Position
Associate Professor
Other areas of specialty/work
Street address
Ali Ebne Abi Taleb Hospital, Khalije Fars Blv, Zahedan
City
Zahedan
Postal code
Phone
+98 54 3322 5715
Fax
+98 54 3322 5715
Email
Mahnazsandooghi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Elnaz Langarizadeh
Position
Internal medicine resident
Other areas of specialty/work
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Postal code
Phone
+98 54 3322 5715
Fax
Email
e.langarizadeh@zaums.ac.ir, ayubabedi48@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)