Background: Vitamin D (vitD) deficiency is very common in Iran. According to several study on vitD doses to achieve the optimal level of serum 25(OH)D, we compare high dose vitD with conventional dose, in elderly osteopenic women.
Methods: this study was a one year randomized clinical trial, in Endocrine & Metabolism Research Center of Shariati hospital in 2008-9. The subjects were osteopenic women over 50 years who refer to bone densitometry laboratory. They were received either (group P) 50,000u vitD3 weekly for 3 month then monthly for another 9 month, or (group M) 800u vitD3 daily for one year. 1000 mg calcium carbonate were given to both groups. Serum 25(OH)D, Calcium, Phosphor, PTH was checked at base, 3rd, 6th and 12th month. 24h Urine for calcium were collected before and at the end of trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106126780N1
Registration date:2012-11-21, 1391/09/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-11-21, 1391/09/01
Registrant information
Name
Alireza Bagheri
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2366
Email address
bagheri_a@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences, Vice chanceellor for research, Endocrine & metabolism Research Institute
Expected recruitment start date
2008-09-22, 1387/07/01
Expected recruitment end date
2009-05-05, 1388/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
High dose vitamin D supplement versus conventional dose in women over 50 years with osteoporosis and osteopenia (T Score < -1)
Public title
Comparison of conventional dose with high dose vitamin D in osteoporotic or osteopenic (T Score < -1) women over 50 yrs referring to Shariati Hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Outpatient women over 50 years old who have (T score< -1) in any site on their BMD at Shariati Hospital BMD laboratory. Exclusion Criteria: Vitamin D supplementation in the last 6 months; Glucocorticoid use in last 3 months; Use of Levothyroxine, anticonvulsant drugs, Lithium, Estrogen, Progesterone, Teriparatide, Cyclosporine; History of : Hyperparathyroidism, Hyperthyroidism, Romatoid Arthritis, Ancylosing Spondylitis, Malignancy, CKD (GFR<30), Premature Ovarian Failure.
Age
From 50 years old to 90 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Endocrine and Metabolism Research Institute
Street address
5th floor, Shariati Hospital, North karegar
City
Tehran
Postal code
PO Box: 1411713135
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
00202
Health conditions studied
1
Description of health condition studied
osteoprosis
ICD-10 code
M81.0
ICD-10 code description
Postmenopausal osteoporosis
2
Description of health condition studied
Vitamin D deficiency
ICD-10 code
E55
ICD-10 code description
Vitamin D deficiency
Primary outcomes
1
Description
serum 25(OH) D level
Timepoint
at base, 3rd, 6th and 12th month
Method of measurement
ELISA kits Immunodiagnostic Systems Ltd (IDS), Boldon,UK with 5 nmol/L sensitivity
Secondary outcomes
1
Description
Serum Ca
Timepoint
at base, 3rd, 6th and 12th month
Method of measurement
MTB assay, mg/dl
2
Description
Serum P
Timepoint
at base, 3rd, 6th and 12th month
Method of measurement
UV assay, mg/dl
3
Description
Serum PTH
Timepoint
at base, 3rd, 6th and 12th month
Method of measurement
ELISA kits Immunodiagnostic Systems Ltd (IDS), Boldon,UK , with 0/06 pmol/L sensitivity
4
Description
24 Hours Urine for Calcium
Timepoint
at base and 12th month
Method of measurement
MBT assay, mg/dl
Intervention groups
1
Description
50,000u vitamin D3 pearl, weekly for 3 month then monthly for another 9 month
Category
Treatment - Drugs
2
Description
control : 400 iu vitamin D3 tablet twice a day for one year
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
BMD Clinic in Shariati Hospital
Full name of responsible person
Alireza Bagheri, Internal Medicine resident
Street address
Shariati Hospital, North Karegar
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Endocrine and Metabolism Research Institute, Tehran Univercsity of Medical Sciences
Full name of responsible person
Mohamadreza Amini
Street address
5th floor, Shariati Hospital, North Karegar
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Endocrine and Metabolism Research Institute, Tehran Univercsity 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
Endocrinology and Metabolism Research Institute
Full name of responsible person
Akbar Soltani
Position
Endocrinologist, associated professor, Tehran Univercsity of Medical Sciences
Other areas of specialty/work
Street address
5th floor, EMRI, , Shariati Hospital, North Kargar Ave
City
Tehran
Postal code
1411413137
Phone
+98 21 8026 9023
Fax
Email
soltania@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Endocrinology and Metabolism Research Institute
Full name of responsible person
Hamidreza Aghai Meybodi
Position
Endocrinologist, Assistant Professor
Other areas of specialty/work
Street address
5th floor, EMRI, Shariati Hospital - North Kargar ave
City
Tehran
Postal code
1411413137
Phone
+98 21 8822 0037
Fax
Email
hraghai@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Bagheri
Position
Internal Medicine resident
Other areas of specialty/work
Street address
Department of Internal Medicine, Shariati Hospital, North Karegar
City
Tehran
Postal code
۱۴۱۱۷۱۳۱۳۵
Phone
+98 21 8490 2923
Fax
+98 21 8490 2366
Email
bagheri_a@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)