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Effect of Vitamin D on Metabolic Profile in Overweight or Obese Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01344161
First Posted: April 28, 2011
Last Update Posted: October 11, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Shahid Beheshti University of Medical Sciences
Information provided by (Responsible Party):
Tehran University of Medical Sciences
  Purpose
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.

Condition Intervention Phase
Overweight Obesity Dietary Supplement: Placebo Dietary Supplement: vitamin D Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Vitamin D on Metabolic Profile in Overweight or Obese Women

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Change in Body Fat Mass [ Time Frame: 3 months minus baseline ]
    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 [ Time Frame: 3 months minus baseline ]
  • Change in Post Load Glucose Concentrations [ Time Frame: 3 months minus baseline ]
    It was performed 2 hours after 75g oral glucose tolerance test (75-OGTT).

  • Change in Insulin Concentrations [ Time Frame: 3 months minus baseline ]

Enrollment: 85
Study Start Date: October 2009
Study Completion Date: March 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Lactose Dietary Supplement: Placebo
dosage form:lactose dosage: 25 micrograms frequency: every day duration: 12weeks
Other Name: Lactose
Experimental: Vitamin D Dietary Supplement: vitamin D
dosage form:cholecalciferol dosage: 25 micrograms (1000 International Unit) frequency: every day duration: 12weeks
Other Name: Cholecalciferol

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01344161


Locations
Iran, Islamic Republic of
Tehran University of Medical Sciences
Tehran, Iran, Islamic Republic of, 1416783913
Sponsors and Collaborators
Tehran University of Medical Sciences
Shahid Beheshti University of Medical Sciences
Investigators
Study Director: Farzad Shidfar, PhD Tehran University of Medical Sciences
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01344161     History of Changes
Other Study ID Numbers: IRCT138809092709N2
First Submitted: April 18, 2011
First Posted: April 28, 2011
Results First Submitted: July 25, 2011
Results First Posted: July 3, 2012
Last Update Posted: October 11, 2012
Last Verified: October 2012

Keywords provided by Tehran University of Medical Sciences:
Vitamin D
Metabolic profile
Overweight
Obesity

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents