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Effect of VitaminD on Metabolic Profile in Overweight or Obese Womens.

Protocol summary

Summary
Main Objective of this study was assessment of effect of vitamin D supplementation on metabolic profile in the overweight or obese women. In this clinical trial Healthy and overweight or obese women (n=80) with 18-45 years old who referred to clinics of Iran University of Medical Sciences were randomly assigned as a double blind manner into one of following groups based on BMI and age. The intervention group received vitamin D supplement 1 tablet/day (1000 IU vitamin D/tablet) and control group received placebo (lactose) for 12 weeks. 24h dietary recall and food frequency questionnaire, international physical activity questionnaire, anthropometric indices and blood pressures, serum lipid and lipoprotein profile, Apo A-1, Apo B-100, 25(OH)D, calcium and Phosphorus, parathyroid hormone, leptin, insulin, Fasting glucose, and 2-h Post-load serum glucose after 75-oral glucose tolerate test were determined at the baseline and after 12 weeks (90 days).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138809092709N2
Registration date: 2010-02-06, 1388/11/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-02-06, 1388/11/17
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 University of Medical Sciences, Research Institute for Endocrine Sciences of Shaheed Beheshti University of Medical Sciences
Expected recruitment start date
2009-11-21, 1388/08/30
Expected recruitment end date
2010-01-05, 1388/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of VitaminD on Metabolic Profile in Overweight or Obese Womens.
Public title
Effect of VitaminD on Metabolic Profile in Overweight or Obese Womens.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age of 18–45 years (before menopause), Body Mass Index≥25 (BMI; in kg/m2 calculated as weight in kilograms divided by the square of the height in meters), No Use of Dietary Supplements, Absence of Menopause, Stable Body Weight (body weight change ≥3 kg) for 2 mo before intervention, Good general Health, No Smoking, Normal Blood Pressure Values (≤160/95mm Hg), Cholesterol Concentrations not Requiring Pharmaceutical Treatment, Normal Thyroid Function, No use of Medication that could affect body weight, No participation in another clinical trial within 6 mo of screening, No breastfeeding or pregnancy. Exclusion criteria: History of Osteoporosis, Rheumatic Disease, Diabetes Mellitus, Epilepsy, Renal Disease under Hemodialysis, Liver disease, Gastrointestinal Disease, Myocardial infarction, Angina Pectoris, Heart Valve Disease, or Pacemaker Implantation. Compliance less than 70 out of 90 prescribed tablets
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 80
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
Ethic Committee School of Health, Iran University of Medical Sciences
Street address
Arjantin Square, Alvand Street, School of Health, Iran University of Medical Sciences
City
Tehran
Postal code
1516846514
Approval date
2009-03-14, 1387/12/24
Ethics committee reference number
327/5د/26پ

Health conditions studied

1

Description of health condition studied
Overweight or Obese
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories

Primary outcomes

1

Description
Overweight or Obese
Timepoint
Every Month for 3 months
Method of measurement
Anthropometric Index, Bioelectric Impedance

Secondary outcomes

1

Description
Insulin Resistance
Timepoint
3 months
Method of measurement
75-OGTT

2

Description
Hyperlipidemia
Timepoint
3 months
Method of measurement
serum lipid levels

3

Description
Hypertension
Timepoint
Every Month for 3 months
Method of measurement
Measurement of Blood Pressure

Intervention groups

1

Description
Control group: 25 mcg Lactose for 90 days
Category
Treatment - Drugs

2

Description
Intervention group: 1000 IU Vitamin D for 90 days
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Iran University of Medical Sciences
Full name of responsible person
Dr.Farzad Shidfar
Street address
School of Medicine, Crossroads of Shahid Hemmat and Shahid Chamran Expressways,
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohsen Asadi Lari
Street address
School of Medicine, Crossroads of Shahid Hemmat and Shahid Chamran Expressways
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Farzad Shidfar
Position
PhD of Nutrition
Other areas of specialty/work
Street address
School of Medicine, Crossroads of Shahid Hemmat and Shahid Chamran Expressways
City
Tehran
Postal code
1449614525
Phone
+98 21 8860 2218
Fax
+98 88602219
Email
shidfar44@iums.ac.irfarzadshidfar@yahoo.com
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
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Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
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