Ignite Creation Date:
2025-12-24 @ 12:50 PM
Ignite Modification Date:
2025-12-28 @ 10:54 AM
Study NCT ID:
NCT01344161
Status:
COMPLETED
Last Update Posted:
2012-10-11
First Post:
2011-04-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Vitamin D on Metabolic Profile in Overweight or Obese Women
Sponsor:
Tehran University of Medical Sciences
Organization:
Study Overview
Official Title:
Effect of Vitamin D on Metabolic Profile in Overweight or Obese Women
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: