The aim of this study is to compare the effectiveness of different methods of vitamin D administration in patients who are suffering from vitamin D deficiency or inadequacy. Serum 25 (OH) D3 will be measure 3 months and 6 months after the administration of vitamin D. This is an open label randomized clinical trial or interventional study. The study population: All patients in whom level of 25 (OH) D3 is in the range of deficient or inadequate and are eligible to enter. Exclusion criteria: People who are exposed to out of the ordinary types of light; are pregnant; have malabsorption diseases (based on clinical practice.) Inclusion criteria: Age between 18 to 60 years, no evidence of liver or kidney disease. 92 subjects were randomly divided into two groups with block randomization method. Oral vitamin D group: 46 patients received six pearls of 50.000 units oral vitamin D. Parenteral vitamin D group: 46 patients received one IM injection of 300.000 unit bolus vitamin D. After three and six months the effects of these methods will be assessed by measuring blood levels of 25 OH D3.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201010174950N1
Registration date:2010-11-22, 1389/09/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-11-22, 1389/09/01
Registrant information
Name
Mozhdeh Zabihiyeganeh
Name of organization / entity
Tehran University of Medical Scienses
Country
Iran (Islamic Republic of)
Phone
+98 21 2277 0699
Email address
m.zabihiyeganeh@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
goverment
Expected recruitment start date
2010-10-15, 1389/07/23
Expected recruitment end date
2011-03-18, 1389/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the same dose of oral and parentral vitamin D in treatment of vitamin D insufficiency
Public title
What is the best way for treatment of vitamin D deficiency and insufficiency?
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients referred to the Rheumatology clinic of Firouzgar Hospital for whom the level of 25(OH) D3 is in the range of inadequate or insufficient. Exclusion criteria: 1 - People who consume vitamin D during the study orally or have plans to inject outside the study program 2 – People who are exposed to out of the ordinary types of light 3 - Pregnant 4 - malabsorption diseases (based on clinical practice.) 5 - age less than 18 years of age. 6 -age more than 60 years of age. 7 - Liver or kidney diseases
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran university of medical scienses
Street address
Shahid Hemat high way
City
Tehran
Postal code
Approval date
empty
Ethics committee reference number
1.849
Health conditions studied
1
Description of health condition studied
vitamine D defiecy
ICD-10 code
E 55
ICD-10 code description
Vitamin D deficiency
Primary outcomes
1
Description
serum vitamin D level
Timepoint
Before intervention, 3 month after treatment, 6 month after treatment.
Method of measurement
RIA laboratory test by using Biosource Europe’s kit
Secondary outcomes
empty
Intervention groups
1
Description
Oral vitamin D group: 46 patients received six pearls of 50.000 units oral vitamin D
Category
Treatment - Drugs
2
Description
Parenteral vitamin D group: 46 patients received one IM injection of 300.000 unit bolus vitamin D
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Firouzgar Hospital
Full name of responsible person
Mozhdeh Zabihiyeganeh, Assistant professor of rheumatology
Street address
Unit 10, No.133, Mehr building, 9th Golestan, Pasdaran street.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran university of medical scienses
Full name of responsible person
Maziar Moradilale
Street address
Vice chancenllor for research, Tehran university of medical sciences,Hemat 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 scienses
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
Tehran university of medical scienses
Full name of responsible person
mozhdeh zabihiyeganeh
Position
Assistant professor of rheumatology
Other areas of specialty/work
Street address
unit 10, No 133, 9th Golestan, Pasdaran street.
City
Tehran
Postal code
Phone
+98 21 2277 0699
Fax
+98 21 2277 0699
Email
mozhdehzabihi@yahoo.co.uk
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mozhdeh Zabihiyeganeh
Position
Assistant professor of rheumatology
Other areas of specialty/work
Street address
Unit 10, No 133, 9th Golestan, Pasdaran Street.
City
Tehran
Postal code
Phone
+98 21 2277 0699
Fax
+98 21 2277 0699
Email
mozhdehzabihi@yahoo.co.uk
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran university of medical scienses
Full name of responsible person
Mozhdeh Zabihiyeganeh
Position
Assistant professor of rheumatology
Other areas of specialty/work
Street address
Unit 10, No:133, 9th Golestan, Pasdaran Street.
City
Tehran
Postal code
Phone
+98 21 2277 0699
Fax
+98 21 2277 0699
Email
mozhdehzabihi@yahoo.co.uk
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)