In spite of several studies, the impact of homocysteine level and folic acid supplementation on biochemical bone markers has not been established. In this study we aimed to find out the impact of folic acid supplementation and homocysteine on bone bio-markers in 6 months.
Forty postmenopausal osteoporotic women enrolled in the study. All participants randomized to take folic acid tablet 1 mg or placebo on daily basis. At baseline, 3 months and 6 months post intervention the level of homocysteine, vitamin B12, and bone bio-markers were measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014042217385N1
Registration date:2014-05-20, 1393/02/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-05-20, 1393/02/30
Registrant information
Name
Pooneh Salari
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6641 9661
Email address
salari@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2011-07-01, 1390/04/10
Expected recruitment end date
2012-07-01, 1391/04/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Folic Acid on Bone Metabolism in Post-Menopausal Osteoporotic Women: A Randomized Double Blind Clinical Trial
Public title
Effect of Folic Acid on Bone Metabolism: A Randomized Double Blind Clinical Trial in Postmenopausal osteoporosis Women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Age= 50-60yrs; Postmenopausal Women; Osteoporosis.
Exclusion Criteria: History of Cancer; Acute Infection; Endocrinologic Diseases; Taking Medicines Affecting Bone Metabolism Such As Corticosteroids;Gonadotropine Releasing Hormone (GnRH) Analogues; Anticonvulsant Drugs; Heparin; Aluminum Containing Antacids; Thyroid Hormones.
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
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 the Endocrinology and Metabolism Research Institute of the Tehran University of
Street address
5th Floor, Shariati Hospital, Al-e-Ahmad High Way
City
Tehran
Postal code
Approval date
2011-03-02, 1389/12/11
Ethics committee reference number
00102
Health conditions studied
1
Description of health condition studied
Osteoporosis
ICD-10 code
M81.0
ICD-10 code description
Senile Osteoporosis
Primary outcomes
1
Description
Pyridinoline
Timepoint
At Baseline, 3 and 6 Months Later
Method of measurement
µg/mmol cr
2
Description
Osteocalcin
Timepoint
At Baseline, 3 and 6 Months Later
Method of measurement
ng/ml
3
Description
Bone Alkaline Phosphatase
Timepoint
At Baseline, 3 and 6 Months Later
Method of measurement
U/L
4
Description
U β Cross Laps
Timepoint
At Baseline, 3 and 6 Months Later
Method of measurement
µg/mmol cr
5
Description
Bone density
Timepoint
Before
Method of measurement
Gm/cm2
Secondary outcomes
empty
Intervention groups
1
Description
Folic Acid Tablet 1 mg/day
Category
Prevention
2
Description
Placebo 1 Tablet Per Day
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Center, Endocrinology and Metabolism Research Institute of Tehran University of Medical Sci
Full name of responsible person
Miss Shirazi
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mehrdad
Street address
5th Floor, Shariati Hospital, Al-e-Ahmad High Way
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Medical Ethics and History of Medicine Research Center of Tehran University of Medical Sciences
Full name of responsible person
Pooneh Salari
Position
Specialist in Clinical Pharmacy, Assistant Professor
Other areas of specialty/work
Street address
23# 16 Azar Ave
City
Tehran
Postal code
Phone
+98 21 6641 9661
Fax
+98 21 6641 9661
Email
poonehsalari@gmail.com; salari@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medical Ethics and History of Medicine Research Center of Tehran University of Medical Sciences
Full name of responsible person
Pooneh Salari
Position
Specialist in Clinical Pharmacy
Other areas of specialty/work
Street address
23# 16 Azar Ave
City
Tehran
Postal code
Phone
+98 21 6641 9661
Fax
+98 21 6641 9661
Email
poonehsalari@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Medical Ethics and History of Medicine Research Center of Tehran University of Medical Sciences
Full name of responsible person
Pooneh Salari
Position
Specialist in Clinical Pharmacy
Other areas of specialty/work
Street address
23# 16 Azar Ave
City
Tehran
Postal code
Phone
+98 21 6641 9661
Fax
+98 21 6641 9661
Email
poonehsalari@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)