The objective of this study is to evaluate the effect of omega 3 fatty acid on bone formation and resorption markers in osteoporotic spinal cord injured patients. Eighty spinal cord injured patients with osteoporosis who come to clinic of spinal injury repair research center receive an injection of vitamin D (300,000 IU). Then one month later, the patients will receive two supplements of Calcium-D capsule (containing 500 mg calcium and 200 IU vitamin D) as well as two capsules of omega 3 (600 mg) in the intervention group and placebo in the control group. Primary outcome measures are serum IL1, IL6, TNFα, b-ALP, OPG, NTx, RANKL, and osteocalcin.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138905102709N7
Registration date:2010-08-28, 1389/06/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-08-28, 1389/06/06
Registrant information
Name
Farzad Shidfar
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8862 2755
Email address
shidfar.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Brain and Spinal Injury Repair Research Center, Endocrinology and Metabolism Research Center
Expected recruitment start date
2010-08-23, 1389/06/01
Expected recruitment end date
2011-03-21, 1390/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of omega 3 fatty acid on bone formation and resorption markers in osteoporotic spinal cord injured patients
Public title
Effect of omega 3 fatty acid on bone formation and resorption markers in osteoporotic spinal cord injured patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: no metabolic, malignant or kidney disorder, BMD: Z score <-2, normal TSH, LH, FSH, prolactin, and testosterone in men and normal prolactin, estradiol, LH, FSH, and TSH in women
Exclusion criteria: pregnancy, lactation, presence of bone disease, hypersensitivity to fish or fish oil, hypertension
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Ethic committee of School of Public health of Iran University of Medical Sciences
Street address
No.52, Alvand avenue, Argantine aquare
City
Tehran
Postal code
Approval date
empty
Ethics committee reference number
1421
Health conditions studied
1
Description of health condition studied
Injury of spinal cord, level unspecified
ICD-10 code
T09.3
ICD-10 code description
Injury of spinal cord, level unspecified
Primary outcomes
1
Description
IL-6
Timepoint
before intervention and four months after intervention
Method of measurement
ELIZA
2
Description
RANKL
Timepoint
before intervention and four months after intervention
Method of measurement
ELIZA
3
Description
Osteoprotegrin
Timepoint
before intervention and four months after intervention
Method of measurement
ELIZA
4
Description
b-ALP
Timepoint
before intervention and four months after intervention
Method of measurement
ELIZA
5
Description
TNF- α
Timepoint
before intervention and four months after intervention
Method of measurement
ELIZA
Secondary outcomes
empty
Intervention groups
1
Description
Injection of two vitamin D ampules (300,000 IU), then one month later, two supplements of Calcium-D capsule (containing 500 mg calcium and 200 IU vitamin D) as well as two capsules of omega 3 (600 mg) for four months
Category
Treatment - Drugs
2
Description
Injection of two vitamin D ampules (300,000 IU), then one month later, two supplements of Calcium-D capsule (containing 500 mg calcium and 200 IU vitamin D) as well as two placebo capsules for four months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Brain and Spinal Injury Repair Reseach Center
Full name of responsible person
Dr. Hadis Sabour
Street address
Brain and Spinal Injury Research Center, Imam Khomeini Hospital, Tehran University of Medical Sciences, Keshavarz Blvd., Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Brain and Spinal Injury Repair Research Center-Endocrine & Metabolism Research Institute
Full name of responsible person
dr.hadis sabour-ِDr Ramin Heshmat
Street address
Keshavarz Blvd . Tehran 14185, IRAN-KARGAR BLVD-5 FLOOR-METABOLISM RESEARCH CENTER
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Brain and Spinal Injury Repair Research Center-Endocrine & Metabolism Research Institute
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Dr. Hadis Sabour
Street address
No.52, Alvand avenue, Argantine aquare
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Science
Proportion provided by this source
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
Brain and Spinal Injury Research Center,
Full name of responsible person
Dr. Hadis Sabour
Position
Nutrition group
Other areas of specialty/work
Street address
Brain and Spinal Injury Research Center, Imam Khomeini Hospital, Tehran University of Medical Sciences, Keshavarz Blvd., Tehran
City
Tehran
Postal code
Phone
+98 21 6658 1560
Fax
Email
hsabour@farabi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Brain and Spinal Injury Repair Research Center
Full name of responsible person
Dr Hadis Sabour
Position
MD-PHD-candidate
Other areas of specialty/work
Street address
5th floor, Brain and Spinal Injury Repair Research Center, Keshavarz Blvd.,
City
Tehran
Postal code
Phone
+98 21 6658 1560
Fax
Email
hsabour@farabi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)