Effect of Vitamin D on Metabolic Profile in Overweight or Obese Women
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| ClinicalTrials.gov Identifier: NCT01344161 |
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Recruitment Status :
Completed
First Posted : April 28, 2011
Results First Posted : July 3, 2012
Last Update Posted : October 11, 2012
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Overweight Obesity | Dietary Supplement: Placebo Dietary Supplement: vitamin D | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 85 participants |
| 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 |
| Study Start Date : | October 2009 |
| Actual Primary Completion Date : | February 2010 |
| Actual Study Completion Date : | March 2010 |
| Arm | Intervention/treatment |
|---|---|
| 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 |
- 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 ]
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| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
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
| Iran, Islamic Republic of | |
| Tehran University of Medical Sciences | |
| Tehran, Iran, Islamic Republic of, 1416783913 | |
| Study Director: | Farzad Shidfar, PhD | Tehran University of Medical Sciences |
| Responsible Party: | Tehran University of Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT01344161 |
| Other Study ID Numbers: |
IRCT138809092709N2 |
| First Posted: | April 28, 2011 Key Record Dates |
| Results First Posted: | July 3, 2012 |
| Last Update Posted: | October 11, 2012 |
| Last Verified: | October 2012 |
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Vitamin D Metabolic profile Overweight Obesity |
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Overweight Body Weight Vitamin D Cholecalciferol Vitamins |
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