This is a prospective, double-blinded, randomized study to evaluate the effects of vitamin D supplementation on plasma anti aging protein klotho in people older than 60 years old, who live in kahrizak old people’s home. participants should be non-diabetic, without a history of stroke or Severe cardiovascular disease, without kidney disease and have vitamin D deficiency. 90 participant randomized in 2 groups: receive 50000 IU/d vitamin D weekly and receive placebo weekly.The duration of intervention is 12 weeks. Patient's blood sample is taken before and after the intervention.The questionnaire about personal information, physical activity, recall diet, sun exposure and cognition is completed by experts. Anthropometric measurement include height, weight, waist circumference and blood pressure will be done based on standard
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201511152709N36
Registration date:2016-02-18, 1394/11/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-18, 1394/11/29
Registrant information
Name
Farzad Shidfar
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8862 2755
Email address
shidfar.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran National Science Foundation International Campus of Iran University of medical science
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Supplementation with vitamin D on anti aging protein klotho in old people
Public title
Effects of Supplementation with vitamin D on anti aging protein klotho
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: more than 60 years old; old people with deficiency or insufficiency of serum Vitamin D levels (less than 30ng/ml serum 25-hydroxyvitamin D); Willingness to cooperate in the study; Lack of sensitivity to Vitamin D Supplement; no Consumption of multi vitamin, mineral and omega 3 Supplement; no Consumption of Vitamin D Supplement; Non-diabetic people; Without a history of stroke or Severe card
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Iran University of medical science
Street address
Iran University of medical science, Hemmat Highway
City
Tehran
Postal code
Approval date
2015-11-18, 1394/08/27
Ethics committee reference number
IR.IUMS.REC.1394.9313680002
Health conditions studied
1
Description of health condition studied
vitamin d deficiency
ICD-10 code
E55.9
ICD-10 code description
Vitamin D deficiency, unspecified
Primary outcomes
1
Description
serum soluble klotho
Timepoint
before and after intervention
Method of measurement
ELISA
2
Description
25(OH)D
Timepoint
before and after intervention
Method of measurement
ELISA
3
Description
1,25(OH)2D
Timepoint
before and after intervention
Method of measurement
ELISA
4
Description
FBS
Timepoint
before and after intervention
Method of measurement
Colorimetric
5
Description
HgA1c
Timepoint
before and after intervention
Method of measurement
Ion exchange
6
Description
hs-CRP
Timepoint
before and after intervention
Method of measurement
ELISA
7
Description
Super Oxide Dismutase assay
Timepoint
before and after intervention
Method of measurement
Calorimetry
8
Description
Cognitive function
Timepoint
before and after intervention
Method of measurement
questionnaire
Secondary outcomes
1
Description
blood pressure
Timepoint
Before and after intervention
Method of measurement
Mercury sphygmomanometer
2
Description
weight
Timepoint
before and after intervention
Method of measurement
Digital scale
3
Description
Dietary intake
Timepoint
before and after intervention
Method of measurement
questionare
4
Description
body mass index
Timepoint
before and after intervention
Method of measurement
Calculation
5
Description
physical activity
Timepoint
before and after intervention
Method of measurement
questionare
6
Description
sun exposure
Timepoint
before and after intervention
Method of measurement
questionare
7
Description
drug consumption
Timepoint
before and after intervention
Method of measurement
questionare
8
Description
Smoking
Timepoint
before and after intervention
Method of measurement
questionare
Intervention groups
1
Description
Intervention group: receive 50000IU vitamin D weekly , for 12 weeks.
Category
Treatment - Other
2
Description
Control group: receive vitamin D placebo weekly , for 12 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kahrizak old people's home
Full name of responsible person
maryam jebreel azimzadeh
Street address
Hakimzadeh Blvd, Kahrizak old people's home, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
International Campus of Iran University of medical science
Full name of responsible person
Doctor Ghasemi
Street address
Iran University of medical science, Hemmat Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
International Campus of Iran University of medical science
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
Iran University of medical science
Full name of responsible person
Farzad Shidfar
Position
Professor
Other areas of specialty/work
Street address
Iran University of medical science, Hemmat Highway, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8862 2755
Fax
Email
: farzadshidfar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of medical science
Full name of responsible person
Farzad Shidfar
Position
Professor
Other areas of specialty/work
Street address
Iran University of medical science, Hemmat Highway, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8862 2755
Fax
Email
farzadshidfar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of medical science
Full name of responsible person
Farzad Shidfar
Position
Professor
Other areas of specialty/work
Street address
Iran University of medical science, Hemmat Highway
City
Tehran
Postal code
Phone
+98 21 8862 2755
Fax
Email
farzadshidfar@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)