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

This study has been completed.
Sponsor:
Collaborator:
Shahid Beheshti Medical University
Information provided by (Responsible Party):
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01344161
First received: April 18, 2011
Last updated: October 9, 2012
Last verified: October 2012

April 18, 2011
October 9, 2012
October 2009
February 2010   (final data collection date for primary outcome measure)
  • Change in Body Fat Mass [ Time Frame: 3 months minus baseline ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • Change in Post Load Glucose Concentrations [ Time Frame: 3 months minus baseline ] [ Designated as safety issue: Yes ]
    It was performed 2 hours after 75g oral glucose tolerance test (75-OGTT).
  • Change in Insulin Concentrations [ Time Frame: 3 months minus baseline ] [ Designated as safety issue: Yes ]
Body Fat Mass [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01344161 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Effect of Vitamin D on Metabolic Profile in Overweight or Obese Women
Effect of Vitamin D on Metabolic Profile in Overweight or Obese Women

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Overweight
  • Obesity
  • Dietary Supplement: Placebo
    dosage form:lactose dosage: 25 micrograms frequency: every day duration: 12weeks
    Other Name: Lactose
  • Dietary Supplement: vitamin D
    dosage form:cholecalciferol dosage: 25 micrograms (1000 International Unit) frequency: every day duration: 12weeks
    Other Name: Cholecalciferol
  • Placebo Comparator: Lactose
    Intervention: Dietary Supplement: Placebo
  • Experimental: Vitamin D
    Intervention: Dietary Supplement: vitamin D

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
85
March 2010
February 2010   (final data collection date for primary outcome measure)

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
Female
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01344161
IRCT138809092709N2
Yes
Tehran University of Medical Sciences
Tehran University of Medical Sciences
Shahid Beheshti Medical University
Study Director: Farzad Shidfar, PhD Tehran University of Medical Sciences
Tehran University of Medical Sciences
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP