The present study was designed to evaluate the effects of monthly and bimonthly consumption of 50000 units of oral D3 on Serum levels of 1-25(OH)D and comparison of the result with placebo in 210 healthy students who did not take any medications affecting bone metabolism during fall and winter 2007-2008 in Taleghan. The participants were assigned to 3 groups to receive 50000 units vitamin D3 monthly, 50000 units vitamin D3 bimonthly, or placebo. Serum levels of 1-25(OH)D were evaluated at the beginning, middle and the end of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201009131681N2
Registration date:2010-09-15, 1389/06/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-09-15, 1389/06/24
Registrant information
Name
Ali Asghar Mirsaeid Ghazi
Name of organization / entity
Research institue for endocrine sciences, Shahid Beheshti University of Medical Sciences (MC)
Country
Iran (Islamic Republic of)
Phone
+98 21 2240 9309
Email address
ghazi@endocrine.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2007-07-20, 1386/04/29
Expected recruitment end date
2008-03-20, 1387/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of different doses of oral Cholecalciferol on serum1-25(OH)D during Fall and Winter in school children of Taleghan
Public title
vitamin D status in school children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: healthy active students
Exclusion criteria: Presence of disorders affecting bone metabolism, taking supplements or drugs affecting bone metabolism
Age
From 14 years old to 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
210
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
Shahid Beheshti University of Medical Sciences
Street address
Parvane ST., Yemen Ave., Velenjak,
City
Tehran
Postal code
Approval date
2010-08-29, 1389/06/07
Ethics committee reference number
88
Health conditions studied
1
Description of health condition studied
Status of vitamin D in school children
ICD-10 code
E55.9
ICD-10 code description
Vitamin D deficiency, unspecified
Primary outcomes
1
Description
serum levels of 1-25(OH)D
Timepoint
at the begining, middle, and end of the study
Method of measurement
RIA
Secondary outcomes
1
Description
serum levels of bone specific alkaline phosphatase
Timepoint
At the beginning, middle, and the end of the study
Method of measurement
IRA
2
Description
serum levels of Calcium
Timepoint
At the beginning, middle, and the end of the study
Method of measurement
IRA
3
Description
serum levels of 25-OHD
Timepoint
at the begining, middle, and end of the study
Method of measurement
RIA
4
Description
serum levels of iPTH
Timepoint
At the beginning, middle, and the end of the study
Method of measurement
IRA
5
Description
serum levels of osteocalcin
Timepoint
At the begining, middle, and end of the study
Method of measurement
IRA
6
Description
24 hour urine c-telopeptide
Timepoint
At the beginning, middle, and the end of the study
Method of measurement
IRA
Intervention groups
1
Description
50 000 units of oral vitamin D3 monthly during 6 months
Category
Treatment - Drugs
2
Description
50 000 units of oral vitamin D3 bimonthly during 6 months
Category
Treatment - Drugs
3
Description
Placebo monthly, similar to the real drug in shape for 6 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
high schools of Shahrak, centre of Taleghan
Full name of responsible person
Mr. Noroozi
Street address
City
Shahrak, Taleghan,
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali A.M. Ghazi MD
Street address
Parvane ST., Yemen Ave., Velenjak
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali A.M.Ghazi MD
Position
Professor of Internal Medicine and Endocrinology
Other areas of specialty/work
Street address
Taleghani Hospital
City
Tehran
Postal code
1985717413
Phone
+98 21 2240 9309
Fax
Email
ghazi@endocrine.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali A.M.Ghazi MD
Position
Professor of Internal Medicine and Endocrinology
Other areas of specialty/work
Street address
Taleghani Hospital
City
Tehran
Postal code
Phone
+98 21 2240 9309
Fax
Email
ghazi@endocrine.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Siavash M.Ghazi MD
Position
MD
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
+98 21 8808 7505
Fax
Email
siavashmsgh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)