Effect of Vitamin D on Metabolic Profile in Overweight or Obese Women
NCT ID: NCT01344161
Last Updated: 2012-10-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
85 participants
INTERVENTIONAL
2009-10-31
2010-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Lactose
Placebo
dosage form:lactose dosage: 25 micrograms frequency: every day duration: 12weeks
Vitamin D
vitamin D
dosage form:cholecalciferol dosage: 25 micrograms (1000 International Unit) frequency: every day duration: 12weeks
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18-50 years old
* Premenopause
* BMI ≥25
Exclusion Criteria
* Liver disease
* Gastrointestinal disease
* Kidney disease
* Diabetes mellitus
* Osteoporosis
* Pregnancy
* Lactation
18 Years
50 Years
FEMALE
Yes
Sponsors
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Shahid Beheshti University of Medical Sciences
OTHER
Tehran University of Medical Sciences
OTHER
Responsible Party
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Principal Investigators
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Farzad Shidfar, PhD
Role: STUDY_DIRECTOR
Tehran University of Medical Sciences
Locations
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Tehran University of Medical Sciences
Tehran, Tehran Province, Iran
Countries
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References
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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.
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.
Other Identifiers
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IRCT138809092709N2
Identifier Type: -
Identifier Source: org_study_id