each participant is given both 1000IU vitamin D or its placebo and 50000IU vitamin D or it's placebo in order to make the participant blind
Participants/Inclusion and exclusion criteria
people who have not used calcium and vitamin D supplements in the last 2 months
lack of liver and kidney failure
lack of steatorrhea
lack of atherosclerosis
lack of medications that affect vitamin D metabolisms, such as parathormone, estrogen, and calcitonin
lack of sarcoidosis, hyperparathyroidism, renal diseases and histoplasmosis
having a light or moderate physical activity
willingness to cooperate
Those whose serum vitamin D is below 30 ng/ml
Intervention groups
vitamin D deficient subjects were divided into 3 groups: first those who received 1000 IU/day vitamin D plus 50000 IU/month placebo, second group was those who received 50000 IU/month vitamin D besides 1000IU/day vitamin D placebo and the third one was given 1000 IU/day and 50000 IU/day vitamin D placebo.
Main outcome variables
Vitamin D serum level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180214038730N1
Registration date:2018-05-30, 1397/03/09
Registration timing:retrospective
Last update:2018-05-30, 1397/03/09
Update count:0
Registration date
2018-05-30, 1397/03/09
Registrant information
Name
Tahereh Ranjbar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3725 1005
Email address
tranjbar@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-15, 1396/11/26
Expected recruitment end date
2018-04-19, 1397/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of 1000 and 50000 IU vitamin D supplement on serum calcium and vitamin D in adults with vitamin D deficiency
Public title
Effect of 1000 and 50,000 IU vitamin D on serum calcium and vitamin D
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
having light or moderate physical activity
willingness to cooperate
those whose serum vitamin D were below 30 ng/ml in screening
Exclusion criteria:
people who have used calcium and vitamin D supplements in the last 2 months
having liver and kidney failure
having Steatorrhea
having atherosclerosis
using medications that affect vitamin D metabolism, such as parathormone, estrogen and calcitonin
having sarcoidosis, hyperparathyroidism, renal diseases and histoplasmosis
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
block randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
each participant is given both 1000IU vitamin D or its placebo and 50000IU vitamin D or it's placebo in order to make the participant blind
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
7th floor- Central Building of Shiraz University of Medical Sciences- Zand Avenue
City
Shiraz
Province
Fars
Postal code
71345-1978
Approval date
2017-12-10, 1396/09/19
Ethics committee reference number
IR.SUMS.REC.1396.123
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 vitamin D level
Timepoint
at the beginning(before intervention), 61st day after intervention
Method of measurement
Autoanalizer device
Secondary outcomes
1
Description
parathyroid hormones
Timepoint
before the intervention , 61st day after intervention
Method of measurement
auto-analyser device
2
Description
serum calcium level
Timepoint
before the intervention , 61st day after intervention
Method of measurement
auto-analyser device
3
Description
serum phosphorus level
Timepoint
before the intervention , 61st day after intervention
Method of measurement
auto-analyser device
4
Description
fibroblast growth factor 23
Timepoint
before the intervention , 61st day after intervention
Method of measurement
ELISA method
Intervention groups
1
Description
first intervention group: 1000 IU/day vitamin D and placebo of 50000 IU/month vitamin D
Category
Treatment - Other
2
Description
second intervention group: 50000 IU/month vitamin D and placebo of 1000 IU/day vitamin D
Category
Treatment - Other
3
Description
Control group:1000 IU/day and 50000 IU/day vitamin D placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Eram Student Dorm Collection
Full name of responsible person
Ali Ahmadi
Street address
Eram Square
City
Shiraz
Province
Fars
Postal code
00000000000
Phone
+98 71 3212 2464
Email
s.ranjbar94@chmail.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Ali poust forush fard
Street address
7th floor- Central Building of Shiraz University of Medical Sciences- Zand Avenue
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2389
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Masoume Akhlaghi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Science, Razi Blvd
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Email
akhlaghi_m@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Masoume Akhlaghi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences, Razi Blvd
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Email
akhlaghi_m@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Tahereh Ranjbar
Position
MSc Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences, Razi Blvd
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 0000 0000
Email
s.ranjbar9473@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available