The effect of Conjugated linoleic acids on some bone markers, in adult with active rheumatoid arthritis referring to Shariaty Hospital Rheumatology research Centre. center
This study will examine, the effect of Conjugated linoleic acids on some bone markers in patients with active RA, In a randomized, double-blind, placebo controlled clinical trial in shariati Hospital, 46 RA patients between18-69 years old age with Active RA after Rheumatologist examination and filling personal, medical and food questionnaires will be enrolled in the study. They randomly will divide into 2 groups, each group will receive one of the following daily 2 capsules for 3 months; Group C: 2.5 gr glycerinated CLAs(50-50) daily, Group P: placebo 2.5 gr sunflower oil daily. Placebo capsules are completely similar to cases one and will divide randomly between Patients. Patients will be control weekly by calling and in the end of each month by visiting. Before and After the 3 months intervention period this test for comparing two groups will be done:PTH, Osteocalcine, telopeptide C were measured by ELISA method, and Ca by HPLC .
General information
Acronym
The effect of CLAs on some bone markers, in adult with active RA.
IRCT registration information
IRCT registration number:IRCT201403029472N5
Registration date:2014-03-19, 1392/12/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-03-19, 1392/12/28
Registrant information
Name
Naheed Aryaeian
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4750
Email address
aryaeian.n@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-04-16, 1393/01/27
Expected recruitment end date
2014-10-22, 1393/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Conjugated linoleic acids on some bone markers, in adult with active rheumatoid arthritis referring to Shariaty Hospital Rheumatology research Centre. center
Public title
The effect of Conjugated linoleic acids on some bone markers, in adult with active rheumatoid arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: person with RA diseases as ACR criteria, having RA from 2 years ago; age between 18-69 years; not being pregnant or lactated; not smoking and drink alcohol; haven’t eaten multivitamin or antioxidants supplements from 3 month ago; don't eat lowering blood pressure; don't eat anti pregnancy drugs, exclusion criteria: Changes in diet or physical activity every day; taking less than 80% of supplements given to patients at baseline(the compliance lower than %80); consumption of contraceptives, multivitamins and antioxidant supplements; renal , hepatic , thyroid, parathyroid diseases, cancer, heart. diseases.
Age
From 18 years old to 69 years old
Gender
Both
Phase
1
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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran university of medical sciences
Street address
Tehran University of Medical Sciences, Keshavarz Bld, Qods street
City
Tehran
Postal code
Approval date
2014-03-01, 1392/12/10
Ethics committee reference number
92-03-41-24528-107523
Health conditions studied
1
Description of health condition studied
Rheumatoid Arthritis
ICD-10 code
M06.9
ICD-10 code description
Rheumatoid arthritis, unspecified
Primary outcomes
1
Description
Telopeptide C
Timepoint
Before and after the study
Method of measurement
Bleeding and measurment with ELISA
2
Description
Osteocalcine
Timepoint
Before and after the study
Method of measurement
Bleeding and measurment with ELISA
3
Description
Serum PTH
Timepoint
Before and after the study
Method of measurement
Bleeding and measurment with ELISA
4
Description
Serum Calcium
Timepoint
Before and After the study
Method of measurement
Bleeding and measurment with HPLC
Secondary outcomes
1
Description
Nsaid usage
Timepoint
Before and after study
Method of measurement
Questionnair
2
Description
BMI
Timepoint
Before and after study
Method of measurement
Formula
Intervention groups
1
Description
Intervention Group: Patients that refer to hospital shariatti have interval criteria and will receive CLAs supplement voluntarily and they receive daily 2*1.25gr glycerinated CLAs(50-50) capsules for 3 months.
Category
Treatment - Other
2
Description
Control groups: Patients that refer to hospital shariatti have interval criteria and will receive placebo voluntarily and they receive daily 2*1.25gr Sunflower capsules for 3 months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rhumatology research centre
Full name of responsible person
Farhad Shahram
Street address
Shariaty Hospital, Jalal Aleahmad Street
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
Mr Dr Masood Yonesian
Street address
Tehran University of Medical Sciences, Keshavarz Bld, Qods street
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
Iran University of Medical Sciences
Full name of responsible person
Naheed Aryaeian
Position
assistant Professor/PhD in Nutrition
Other areas of specialty/work
Street address
Nutrition faculty, School of public health, Iran University of Medical Sciences, Hammat Bld.
City
Tehran
Postal code
Phone
+98 21 8670 4755
Fax
Email
aryaeian@razi.tums.ac.irnah_arya2002@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences.
Full name of responsible person
Naheed Aryaeian
Position
assistant Professor/PhD in Nutrition
Other areas of specialty/work
Street address
Nutrition faculty, School of public health, Iran University of Medical Sciences, Hammat Bld.
City
Tehran
Postal code
Phone
+98 21 8670 4755
Fax
Email
nah_arya2002@yahoo.comaryaeian@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Naheed Aryaeian
Position
assistant Professor/PhD in Nutrition
Other areas of specialty/work
Street address
Nutrition faculty, School of public health, Iran University of Medical Sciences, Hammat Bld.
City
Tehran
Postal code
Phone
+98 21 8670 4755
Fax
Email
aryaeian@razi.tums.ac.ir nah_arya2002@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)