Effect of Vitamin D on Metabolic Profile in Overweight or Obese Women
Primary Purpose
Overweight, Obesity
Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Placebo
vitamin D
Sponsored by

About this trial
This is an interventional prevention trial for Overweight focused on measuring Vitamin D, Metabolic profile, Overweight, Obesity
Eligibility Criteria
Inclusion Criteria:
- Female
- 18-50 years old
- Premenopause
- BMI ≥25
Exclusion Criteria:
- Cardiovascular disease
- Liver disease
- Gastrointestinal disease
- Kidney disease
- Diabetes mellitus
- Osteoporosis
- Pregnancy
- Lactation
Sites / Locations
- Tehran University of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Lactose
Vitamin D
Arm Description
Outcomes
Primary Outcome Measures
Change in Body Fat Mass
Body composition was assessed by Bioelectrical Impedance Analysis (model 4000; Body Stat Quad Scan, Douglas Isle of Man, British Isles).The principle of measuring the flow of current through the body is dependent on the frequency applied. At low frequencies, the current cannot bridge the cellular membrane and will pass predominantly through the extra-cellular space. At higher frequencies penetration of the cell membrane occurs and the current is conducted by both the extra-cellular water (ECW) and intra-cellular water (ICW).FFM can be estimated because FFM is primarily composed of water.
Change in Glucose Concentrations
Change in Post Load Glucose Concentrations
It was performed 2 hours after 75g oral glucose tolerance test (75-OGTT).
Change in Insulin Concentrations
Secondary Outcome Measures
Full Information
NCT ID
NCT01344161
First Posted
April 18, 2011
Last Updated
October 9, 2012
Sponsor
Tehran University of Medical Sciences
Collaborators
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01344161
Brief Title
Effect of Vitamin D on Metabolic Profile in Overweight or Obese Women
Official Title
Effect of Vitamin D on Metabolic Profile in Overweight or Obese Women
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tehran University of Medical Sciences
Collaborators
Shahid Beheshti University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators investigated the effect of vitamin D3 supplementation on metabolic profile (anthropometric measures, blood pressure Lipids, lipoproteins and glycemic indices) in overweight or obese women.
Detailed Description
Vitamin D deficiency is a worldwide health problem and is determined as a risk factor in Cardiometabolic disorders including Cardiovascular disease, Metabolic syndrome, and type 2 diabetes mellitus. The investigators investigated the effect of vitamin D3 supplementation on metabolic profile in overweight or obese women.
A double blind randomized clinical trial was conducted in 77 premenopause overweight or obese women. Participants were classified into two groups : vitamin D supplementation [1000 IU/day as cholecalciferol tablets (n=39)] or placebo (n=38). Vein blood samples were taken after at least 12 hours overnight fasting. Selected anthropometric measures, blood pressure Lipids, lipoproteins and glycemic indices were measured at baseline and after 12 weeks. Body fat mass was determined using BIA. Also the investigators assessed dietary intake using 24 hours food recall and semi-quantitative food frequency and physical activity using IPAQ questionnaires.
The investigators conducted the study between October 2009 and March 2010 at the Medical school, Tehran, Iran. Recruitment began in October 2009 via advertisements and was terminated in October 2009. The investigators excluded patients with a history of Cardiovascular disease, Liver disease, Gastrointestinal disease, Kidney disease, diabetes mellitus, and Osteoporosis. Moreover, pregnancy, lactation, vegetarianism, and intake of dietary supplements were the exclusion criteria.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Vitamin D, Metabolic profile, Overweight, Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lactose
Arm Type
Placebo Comparator
Arm Title
Vitamin D
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
Lactose
Intervention Description
dosage form:lactose dosage: 25 micrograms frequency: every day duration: 12weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D
Other Intervention Name(s)
Cholecalciferol
Intervention Description
dosage form:cholecalciferol dosage: 25 micrograms (1000 International Unit) frequency: every day duration: 12weeks
Primary Outcome Measure Information:
Title
Change in Body Fat Mass
Description
Body composition was assessed by Bioelectrical Impedance Analysis (model 4000; Body Stat Quad Scan, Douglas Isle of Man, British Isles).The principle of measuring the flow of current through the body is dependent on the frequency applied. At low frequencies, the current cannot bridge the cellular membrane and will pass predominantly through the extra-cellular space. At higher frequencies penetration of the cell membrane occurs and the current is conducted by both the extra-cellular water (ECW) and intra-cellular water (ICW).FFM can be estimated because FFM is primarily composed of water.
Time Frame
3 months minus baseline
Title
Change in Glucose Concentrations
Time Frame
3 months minus baseline
Title
Change in Post Load Glucose Concentrations
Description
It was performed 2 hours after 75g oral glucose tolerance test (75-OGTT).
Time Frame
3 months minus baseline
Title
Change in Insulin Concentrations
Time Frame
3 months minus baseline
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Female
18-50 years old
Premenopause
BMI ≥25
Exclusion Criteria:
Cardiovascular disease
Liver disease
Gastrointestinal disease
Kidney disease
Diabetes mellitus
Osteoporosis
Pregnancy
Lactation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farzad Shidfar, PhD
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Tehran University of Medical Sciences
City
Tehran
ZIP/Postal Code
1416783913
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
23822797
Citation
Salehpour A, Shidfar F, Hosseinpanah F, Vafa M, Razaghi M, Amiri F. Does vitamin D3 supplementation improve glucose homeostasis in overweight or obese women? A double-blind, randomized, placebo-controlled clinical trial. Diabet Med. 2013 Dec;30(12):1477-81. doi: 10.1111/dme.12273. Epub 2013 Jul 27.
Results Reference
derived
PubMed Identifier
22998754
Citation
Salehpour A, Hosseinpanah F, Shidfar F, Vafa M, Razaghi M, Dehghani S, Hoshiarrad A, Gohari M. A 12-week double-blind randomized clinical trial of vitamin D(3) supplementation on body fat mass in healthy overweight and obese women. Nutr J. 2012 Sep 22;11:78. doi: 10.1186/1475-2891-11-78.
Results Reference
derived
Learn more about this trial
Effect of Vitamin D on Metabolic Profile in Overweight or Obese Women
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