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| Name | Class |
|---|---|
| Academy of Finland | OTHER |
| Juho Vainio Foundation | OTHER |
| Finnish Foundation for Cardiovascular Research | OTHER |
| Diabetes Research Foundation, Finland |
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Vitamin D deficiency is widespread throughout the world, and the deficiency has been associated with several chronic diseases, such as cardiovascular diseases and diabetes. In Nordic countries, like in Finland, there is a particular variation in vitamin D status, and during wintertime, when there is no exposure to ultraviolet-B light from the sun, serum concentrations of vitamin D decrease substantially. In Finland, some 40% of middle-aged men and one third of women also have some degree of impairment of glucose metabolism.
The purpose of this trial is to investigate the effects of two different daily doses of vitamin D on glucose metabolism in men 60 years of age or older and who are vitamin D deficient, have a high body mass index and at least two characteristics of cardio-metabolic syndrome.
Altogether 102 subjects with low serum calcidiol (<60 nmol/L) will be recruited and randomized to one of the three groups: 1) 40 µg/d vitamin D3, 2) 80 µg/d vitamin D3 or 3) placebo. The supplementation period will last for 6 months from September 2011 to March 2012.
The main hypotheses of the trial are: (1.) Vitamin D supplementation will improve glucose and insulin metabolism in people with a low baseline vitamin D status, in a dose-dependent manner. (2.) Vitamin D supplementation will have an effect on the expression of genes involved in glucose and insulin metabolism and inflammation. (3.) Vitamin D supplementation will have an effect on epigenetic changes in key genes participating in vitamin D metabolism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D 40 | Experimental | Vitamin D3 40 micrograms (1600 IU) per day |
|
| Vitamin D 80 | Experimental | Vitamin D3 80 micrograms (3200 IU) per day |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Dietary Supplement | Vitamin D3 40 micrograms (1600 IU) per day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin sensitivity | Change in insulin sensitivity measured by oral glucose tolerance test at baseline and after 6 months | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral blood mononuclear cell gene expression | Six months | |
| Inflammation | Change in inflammation measured as serum cytokines and adipose tissue inflammation at baseline and after 6 months | Baseline to six months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tomi-Pekka Tuomainen, MD, PhD | University of Eastern Finland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Eastern Finland, Kuopio Campus | Kuopio | Kuopio | 70211 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24975273 | Derived | Ryynanen J, Neme A, Tuomainen TP, Virtanen JK, Voutilainen S, Nurmi T, de Mello VD, Uusitupa M, Carlberg C. Changes in vitamin D target gene expression in adipose tissue monitor the vitamin D response of human individuals. Mol Nutr Food Res. 2014 Oct;58(10):2036-45. doi: 10.1002/mnfr.201400291. Epub 2014 Jul 28. |
| Label | URL |
|---|---|
| University of Eastern Finland | View source |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D050177 | Overweight |
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| OTHER |
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| Placebo |
| Dietary Supplement |
Inactive placebo |
|
| Vitamin D 80 | Dietary Supplement | Vitamin D3 80 micrograms (3200 IU) per day |
|
| Adipose tissue gene expression | Six months |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |