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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003183-75 | EudraCT Number |
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Hypovitaminosis D is highly prevalent in the general population, particularly in obese individuals. Besides being associated with obesity, vitamin D deficiency seems to be involved in the pathogenesis of insulin resistance and low-grade chronic inflammation. In addition, it has been reported that individuals with low vitamin D levels are at increased risk for cardiovascular diseases. A healthy diet and weight loss are cornerstones in the prevention of cardiovascular diseases. Vitamin D supplementation could increase the beneficial effects of these lifestyle interventions. The purpose of this study is to assess whether vitamin D supplementation in conjunction with a hypocaloric diet improves the cardiometabolic profile of overweight/obese subjects to a greater extent than diet alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D and Diet | Experimental | Cholecalciferol (vitamin D3) 25,000 I.U./2.5 mL oral solution. 25,000 I.U. (one bottle) per week. Hypocaloric diet |
|
| Placebo & Diet | Placebo Comparator | Oral solution mimicking cholecalciferol (vitamin D3) 25,000 I.U./2.5 mL. One bottle per week. Hypocaloric diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Drug |
| ||
| Placebo (for vitamin D) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in insulin sensitivity (M value) | Insulin sensitivity will be measured with the hyperinsulinemic euglycemic clamp technique and expressed as M value, calculated from the glucose infusion rate during the last 30 min of the clamp. | Baseline, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in oral glucose tolerance | Oral glucose tolerance will be assessed with a standard 2-hour oral glucose tolerance test (OGTT). | Baseline, 3 months |
| Change from baseline in body composition |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Giaccari, MD, PhD | Catholic University of the Sacred Heart | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic University of Sacred Heart | Rome | 00168 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22260937 | Background | Muscogiuri G, Policola C, Prioletta A, Sorice G, Mezza T, Lassandro A, Della Casa S, Pontecorvi A, Giaccari A. Low levels of 25(OH)D and insulin-resistance: 2 unrelated features or a cause-effect in PCOS? Clin Nutr. 2012 Aug;31(4):476-80. doi: 10.1016/j.clnu.2011.12.010. Epub 2012 Jan 20. | |
| 21209228 | Background |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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|
Body composition will be determined by using dual energy X-ray absorptiometry (DXA).
| Baseline, 3 months |
| Change from baseline in anthropometric parameters | Weight, BMI, waist and hip circumference, waist/hip ratio. | Baseline, 3 months |
| Change form baseline in systolic and diastolic blood pressure | Baseline, 3 months |
| Change from baseline in phosphocalcic metabolism | Serum vitamin D, PTH and calcium | Baseline, 3 months |
| Change from baseline in inflammatory markers | Interleukin-6 (IL-6), IL-10, adiponectin, TNF-α, C-reactive protein (CRP) and fibrinogen | Baseline, 3 months |
| Muscogiuri G, Sorice GP, Prioletta A, Policola C, Della Casa S, Pontecorvi A, Giaccari A. Will vitamin D reduce insulin resistance? Still a long way to go. Am J Clin Nutr. 2011 Mar;93(3):672-3; author reply 673-4. doi: 10.3945/ajcn.110.009068. Epub 2011 Jan 5. No abstract available. |
| 20587719 | Background | Muscogiuri G, Sorice GP, Prioletta A, Policola C, Della Casa S, Pontecorvi A, Giaccari A. Association of vitamin D with insulin resistance and beta-cell dysfunction in subjects at risk for type 2 diabetes: comment to Kayaniyil et al. Diabetes Care. 2010 Jul;33(7):e99; author reply e100. doi: 10.2337/dc10-0587. No abstract available. |
| 20150902 | Background | Muscogiuri G, Sorice GP, Prioletta A, Policola C, Della Casa S, Pontecorvi A, Giaccari A. 25-Hydroxyvitamin D concentration correlates with insulin-sensitivity and BMI in obesity. Obesity (Silver Spring). 2010 Oct;18(10):1906-10. doi: 10.1038/oby.2010.11. Epub 2010 Feb 11. |
| 29504254 | Derived | Cefalo CMA, Conte C, Sorice GP, Moffa S, Sun VA, Cinti F, Salomone E, Muscogiuri G, Brocchi AAG, Pontecorvi A, Mezza T, Giaccari A. Effect of Vitamin D Supplementation on Obesity-Induced Insulin Resistance: A Double-Blind, Randomized, Placebo-Controlled Trial. Obesity (Silver Spring). 2018 Apr;26(4):651-657. doi: 10.1002/oby.22132. Epub 2018 Mar 4. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |