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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01344161
• Other study ID #: IRCT138809092709N2
• Status: Completed
• Phase: Phase 3
• First received: April 18, 2011
• Last updated: October 9, 2012
• Start date: October 2009
• Est. completion date: March 2010

Study information

• Verified date: October 2012
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: March 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Dietary Supplement:
• Placebo
dosage form:lactose dosage: 25 micrograms frequency: every day duration: 12weeks
• vitamin D
dosage form:cholecalciferol dosage: 25 micrograms (1000 International Unit) frequency: every day duration: 12weeks

Locations

Country	Name	City	State
Iran, Islamic Republic of	Tehran University of Medical Sciences	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences	hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months minus baseline	Yes
Primary	Change in Glucose Concentrations		3 months minus baseline	Yes
Primary	Change in Post Load Glucose Concentrations	It was performed 2 hours after 75g oral glucose tolerance test (75-OGTT).	3 months minus baseline	Yes
Primary	Change in Insulin Concentrations		3 months minus baseline	Yes