Effects of vitamin D supplementation on sirtuin-1, Angiogenesis factors and Matrix metalloproteinases enzmes in Obese subjects with Vitamin D Insufficiency/ Deficiency
This randomized double blind placebo controlled trial design with aim to determine the Effects of vitamin D supplementation on sirtuin-1, Angiogenesis factors and Matrix metalloproteinases enzmes in Obese subjects with Vitamin D Insufficiency/ Deficiency.
According to inclusion and exclusion criteria,44 Obese subjects with Vitamin D Insufficiency/ Deficiency, age between 18 -60 years old and BMI between 30 – 40 kg/m2 will be recruited to the study . Informed written consent form and personality questionnaire will be filled for all of the patients. Participants will be randomly divided into 2 intervention and placebo groups. Subjects in Intervention and Placebo group will receive a bolus dose vitamin D (50000 IU vitamin D weekly) or placebo of vitamin D (edible paraffin) respectively for 12 weeks.
Subjects in two group will receive a weight reduction diet for 12 week. For all of the participants anthropometric measurements evaluated on baseline and again after the intervention. Furthermore, 3 dietary records and physical activity record will be filled at baseline and at the end of weeks 6 and 12. biochemical measurements at first and end of the study will be repeated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201608223320N13
Registration date:2016-11-03, 1395/08/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-11-03, 1395/08/13
Registrant information
Name
Mehrangiz Ebrahimi mamagani
Name of organization / entity
Health & Nutrition faculty of Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 1113
Email address
ebrahimimamagani@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Nutrition Research Center, Tabriz University of Medical Scienses
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-06-21, 1396/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of vitamin D supplementation on sirtuin-1, Angiogenesis factors and Matrix metalloproteinases enzmes in Obese subjects with Vitamin D Insufficiency/ Deficiency
Public title
Effect of vitamin D on obesity
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age of 18-60; BMI= 30-40 Kg/m2; Serum Vitamin D < 50 nmol/L and interesting in participation in research.
Exclusion criteria: Alcohol consumption; smoking; pregnant; lactating; menopausal women; very active subjectes or athletes; diet 3 mounts before research ; Glucose and lipid lowering Drugs ; antihypertensive medication; consumption vit D supplementation and multivitamin mineral during research; use of medication affecting Vitamin D metabolism; subjects suffering from metabolic disease ;cardiovascular diseases;renal diseases ; nephrolithiasis;
liver diseases; thyroid disease; autoimmune disease; cancer.
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:
44
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
The Research Ethics Committee of Tabriz University of Medical Sciences
Street address
Faculty of Nutrition and food science, Attarneyshabouri street, Golgasht street.
City
Tabriz
Postal code
Iran
Approval date
2016-10-16, 1395/07/25
Ethics committee reference number
IR.TBZMED.REC.1395.761
Health conditions studied
1
Description of health condition studied
obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
Inflammatory factors (MCP-1, IL-1 beta)
Timepoint
Beginning and end of the intervention
Method of measurement
ELISA Kit
2
Description
serum Angiogenesis factors
Timepoint
Beginning and end of the intervention
Method of measurement
ELISA Kit
3
Description
matrix metalloproteinases (MMP-2, MMP-9)
Timepoint
Beginning and end of the intervention
Method of measurement
ELISA Kit
4
Description
Sirtuin-1 (Sirt-1)
Timepoint
Beginning and end of the intervention
Method of measurement
ELISA Kit
5
Description
Toll like receptor-4 (TLR-4)
Timepoint
Beginning and end of the intervention
Method of measurement
ELISA Kit
Secondary outcomes
1
Description
Serum level of Vitamin D, calcium, Phosphorus and PTH hormon
Timepoint
Begining and end of intervention
Method of measurement
Vitamin D and PTH by using ELISA, calcium and Phosphorus by using spectrophotometry
2
Description
Fasting Blood Sugar (F.B.S.)
Timepoint
Begining and end of intervention
Method of measurement
Enzymatic method
3
Description
Lipid profile (TC,LDL-c, HDL-c, TG)
Timepoint
Begining and end of intervention
Method of measurement
Triglyceride, total cholesterol and HDL-cholesterol with enzymatic colorometric and LDL-cholesterol with Friedewald equation
4
Description
Serum insulin level and Insulin resistance
Timepoint
Begining and end of intervention
Method of measurement
insulin by using Elisa and Insulin resistance by Calculation of HOMA-IR
5
Description
Anthropometric measurements
Timepoint
Begining and end of intervention
Method of measurement
Weight and Height by using Seca scale and stadiometer respectively, waist to hip ratio will be calculated waist circumference divided to hip circumferenceas, Body mass index (BMI) will be calculated as weight in kilograms divided by the square of height in meters, fat mass and visceral fat mass by using body Analyser
6
Description
Energy , macro and micro nutrients intake
Timepoint
Baseline, 6 weeks and end of the intervention
Method of measurement
3 day Dietary record questionnair
7
Description
Physical activity level
Timepoint
Baseline, 6 weeks and end of the intervention
Method of measurement
International physical activity questionnaire
Intervention groups
1
Description
Intervention groups: receive 50000 IU vit D as blues along with low calorie diet for 12 weeks
Category
Prevention
2
Description
Control group: receive placebo of vitamin D (edible paraffin) with low calorie diet for 12 weeks.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Sheykholrais clinic
Full name of responsible person
Dr. Mehrangiz Ebrahimi Mamagani
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nutrition Research Center, Tabriz University of Medical Scienses
Full name of responsible person
Dr. Alireza Ostadrahimi
Street address
Faculty of Nutrition and food science, Attarneyshabouri street, Golgasht street, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nutrition Research Center, Tabriz 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
Faculty of Nutrition and food science, Tabriz University of Medical Scienses
Full name of responsible person
Soodabeh Aliashrafi
Position
Ph.D. candidate in Nutrition
Other areas of specialty/work
Street address
Faculty of Nutrition and food science, Attarneyshabouri street, Golgasht street.
City
Tabriz
Postal code
Phone
+98 41 3335 7581
Fax
Email
SA.NUT89@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nutrition and food science, Tabriz University of Medical Scienses
Full name of responsible person
Dr. Mehrangiz Ebrahimi Mamagani
Position
Ph.D. of Nutrition
Other areas of specialty/work
Street address
Faculty of Nutrition and food science, Attarneyshabouri street, Golgasht street
City
Tabriz
Postal code
Phone
+98 413335229500
Fax
Email
ebrahimimamagani@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nutrition and food science, Tabriz University of Medical Scienses
Full name of responsible person
Soodabeh Aliashrafi
Position
Ph.D. Candidate in Nutrition
Other areas of specialty/work
Street address
Faculty of Nutrition and food science, Attarneyshabouri street, Golgasht street
City
Tabriz
Postal code
Phone
+98 41 3335 7581
Fax
Email
SA.NUT89@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)