Comparison the effect of oral vitamin D on serum level of 25(OH) vitamin D in two groups of healthy people with vitamin D deficiency with a level more and less than 10 ng/ml
This is a clinical trial aimed to compare the effect of oral vitamin D on serum level of 25(OH) vitamin D in two groups of healthy people with vitamin D deficiency with a level more and less than 10 ng/ml. Study sample consists of 80 persons with a vitamin D level of less than 30 ng/ml and without clinical manifestations. Inclusion criteria are age of 20-40 years and having vitamin D level of less than 30 ng/ml and exclusion criteria are having renal or hepatic diseases, pregnancy or breastfeeding, using steroids or anticonvulsant drugs, using calcium or vitamin D3 supplements during last 6 months, history of hypercalcemia, sarcoidosis, active renal stone or using bisphosphonates. After inclusion in the study, the people will be grouped by their gender into male and female groups. Based on their 25(OH0 vitamin D level, people in each group will be further subgrouped into a group with a vitamin D level less than 10 ng/ml and a group with a vitamin D level between 10 and 30 ng/ml.
All the people will receive 50000 I/U per week oral vitamin D3 for 8 weeks. Then, serum level of 25(OH) vitamin D will be measured at the end of the third month and the mean changes in its serum level will be calculated based on body weight, gender and based on initial 25(OH) vitamin D level. In these people, the mean serum level of PTH will be also compared before and after treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017042433630N1
Registration date:2017-05-20, 1396/02/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-20, 1396/02/30
Registrant information
Name
Mahdie Khodadoost
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5715
Email address
m.khodadoost@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2017-09-20, 1396/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of oral vitamin D on serum level of 25(OH) vitamin D in two groups of healthy people with vitamin D deficiency with a level more and less than 10 ng/ml
Public title
The effect of oral vitamin D on serum level of 25(OH) vitamin D
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age of 20-40 years; having vitamin D level of less than 30 ng/ml. Exclusion criteria: having renal or hepatic diseases; pregnancy or breastfeeding; using steroids or anticonvulsant drugs; using calcium or vitamin D3 supplements during last 6 months; history of hypercalcemia; sarcoidosis; using bisphosphonates.
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
N/A
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 Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Postal code
Approval date
2017-03-05, 1395/12/15
Ethics committee reference number
IR.ZAUMS.REC.1395. 277
Health conditions studied
1
Description of health condition studied
Vitamin D deficiency
ICD-10 code
E55
ICD-10 code description
Vitamin D deficiency
Primary outcomes
1
Description
Serum level of 25(OH) vitamin D
Timepoint
At the start of the study, three months after using vitamin D
Method of measurement
Measurement by laboratory
Secondary outcomes
empty
Intervention groups
1
Description
All the people under study: 50000 I/U per week oral vitamin D3 for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ebne Abi Taleb Hospital
Full name of responsible person
Mahdie Khodadoost
Street address
Khalije Fars Blv, Zahedan
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Zahedan University of Medical Sciences
Full name of responsible person
Hoshang Rafighdoost
Street address
Vice chancellor for research, Zahedan University of Medical Sciences campus, Jannat Blv, Zahedan
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Mahdie Khodadoost
Position
Internal medicine resident
Other areas of specialty/work
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan