Objective: The main objective of this study is to assess the effects of Vitamin D spplementation and low calorie diet on changes in adiposity and regulation of adipokines secreted by adipose tissue to reduce inflammation in the body in an overweight and obese adult population. Design of study: Randomized, double blind, placebo controlled, single center and phase 2-3 trial. Setting and codduct: 70 overweight or obese volunteer age between 20 -50 years old and BMI between 25 – 40 kg/m2 will be recruited.We have 2 groups: 35 persons that will receive vitamin D with weight reduction diet, 35 persons that will receive placebo of vitamin D with weight reduction diet. The duration of intervention is 8 weeks. Participants including major eligibility criteria: Overweight and obese adults 20 -50 years old with BMI between 20 - 40 Kg/m2, having a weight loss diet for 3 months before the study initiation and consumption of Vitamin D, use of tanning bed during and 3 months before study and Vitamin D >30 ng/dl will be excluded participants from study. Intervention: We will start intervention with a bolus dose (50000 IU vit D) in first week along with weight reduction diet and will be followed by daily doses(2000 IU vit D/ day) after a week in intervention group, and control group will receive placebo of vitamin D (edible paraffin) with weight reduction diet for 2 months. Main outcome measures: Omentin, Spexin, s ICAM-1will measure with ELIZA. With BIA method we will measure the fat percent of the body and Viscan devices will be used for observation of visceral adipose tissue changes. (after and before of study).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015090223861N2
Registration date:2015-10-05, 1394/07/13
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-10-05, 1394/07/13
Registrant information
Name
Mitra Zarrati
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4814
Email address
zarrati.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Science, next to the Milad hospital, the intersection of Sheikh Fazlallah and Shahid Chamran, Shahid Hemmat expressway
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Vitamin D supplementation and low calorie diet on serum Omentin ,Spexin , sICAM-1 , hs –CRP and lipid profiles in obese and overwight people
Public title
Effect of Vitamin D supplementation and low calorie diet on regulation of hormones secreted by adipose tissue and lipid profiles in obesity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age of 20-50; BMI= 25-40; don’t taking the glucose and lipid- lowering drugs; interesting in participation in research; without any metabolic disease; CHD; diabetes; without autoimmune disease; cancer; without infection disease in research; no smoking; no alcoholism; without immune system suppressor drugs 6 mounts before research; no menstrual bleeding; without any diet 3 mounts before research; no consumption vit D supplementation and multivitamin mineral during research; without use of medication affecting Vitamin D metabolism; without use of tanning bed during the study and 3 months before study initiation; without renal and hepatic diseases; women without polycystic ovary syndrome exclusion criteria: metabolic; CHD; autoimmune disease and cancer; infection disease in research; smoking; alcoholism; use of immune system suppressor drugs 6 mounts before research; menstrual bleeding; diet 3 mounts before research; consumption vit D supplementation and multivitamin mineral during research; use of medication affecting Vitamin D metabolism; use of tanning bed during the study and 3 months before study initiation; Having renal and hepatic diseases; women with polycystic ovary syndrome; no interesting for participation
Age
From 20 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
75
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
Ethics Committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, next to the Milad hospital, the intersection of Sheikh Fazlallah and Shahid Chamran, Hemmat expressway
City
Tehran
Postal code
1449614535
Approval date
2015-08-04, 1394/05/13
Ethics committee reference number
26191
Health conditions studied
1
Description of health condition studied
Obesity And Overweight
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
Waist circumference
Timepoint
Before and after intervention
Method of measurement
meter
2
Description
Omentin, Spexin, sICAM-1
Timepoint
Before and after intervention
Method of measurement
ELIZA
3
Description
Fat percent
Timepoint
Before and after intervention
Method of measurement
BIA method
4
Description
BMI
Timepoint
Before and after intervention
Method of measurement
Formula
5
Description
Vitamin D
Timepoint
Before and after intervention
Method of measurement
ELIZA
6
Description
FBS, HDL-C
Timepoint
Before and after intervention
Method of measurement
Enzymatic Method
7
Description
Triglyceride, Total cholesterol
Timepoint
Before and after intervention
Method of measurement
Photometric
8
Description
LDL-C
Timepoint
Before and after intervention
Method of measurement
Enzymatic Method
9
Description
hs-CRP
Timepoint
Before and after intervention
Method of measurement
Enzymatic Method
10
Description
Diastolic blood pressure
Timepoint
Before and after intervention
Method of measurement
manometer
11
Description
Exposure of sunlight
Timepoint
Before and after intervention
Method of measurement
questionnaire
12
Description
Systolic blood pressure
Timepoint
Before and after intervention
Method of measurement
manometer
13
Description
Nutritional status
Timepoint
Before and after intervention
Method of measurement
Measurement of energy and nutrients intake using 24-hour dietary recall method and anthropometric measurement using scale and stadiometer
14
Description
Phisical Activity
Timepoint
Before and after intervention
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention groups: receive 50000 IU vit D once in first week as a blues and 2000 IU vit D per day from second week along with low calorie diet that which reduce the weight 0.5 to 1 kg every week for 8 weeks.
Category
Prevention
2
Description
control group: receive placebo of vitamin D (edible paraffin) with low calorie diet that which reduce the weight 0.5 to 1 kg every week for 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran University of Medical Sciences
Full name of responsible person
Cheshmazar
Street address
Faculty of Nutrition, School of Public Health, Iran University of Medical Sciences, next to the Milad hospital, the intersection of Sheikh Fazlallah and Shahid Chamran, Shahid Hemmat expressway
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Seyed Ali Javad Moosavi, Assistant of Research and Technology , Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, next to the Milad hospital, the intersection of Sheikh Fazlallah and Shahid Chamran, Shahid Hemmat expressway
City
Tehran
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, Iran 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
Iran University of Medical Sciences, School of Public Health
Full name of responsible person
Dr Mitra Zarrati
Position
Assistant Professor
Other areas of specialty/work
Street address
Faculty of Nutrition, School of Public Health, Iran University of Medical Sciences, next to the Milad hospital, the intersection of Sheikh Fazlallah and Shahid Chamran, Shahid Hemmat expressway
City
Tehran
Postal code
1449614535
Phone
+98 21 8670 4814
Fax
Email
zarrati.m@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Mitra Zarrati
Position
Assistant Professor
Other areas of specialty/work
Street address
Faculty of Nutrition, School of Public Health, Iran University of Medical Sciences, next to the Milad hospital, the intersection of Sheikh Fazlallah and Shahid Chamran, Shahid Hemmat expressway
City
Tehran
Postal code
Phone
+98 21 8670 4814
Fax
Email
zarrati.m@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University Of medical sciences
Full name of responsible person
Elhameh Cheshmazar
Position
MS.c student in Nutrition Science
Other areas of specialty/work
Street address
Faculty of Nutrition, School of Public Health, Iran University of Medical Sciences, next to the Milad hospital, the intersection of Sheikh Fazlallah and Shahid Chamran, Shahid Hemmat expressway
City
Tehran
Postal code
Phone
00
Fax
Email
cheshmazar.elham@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)