Glucose Metabolism Effects of Vitamin D Supplementation in Prediabetes (VitDmet)
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ClinicalTrials.gov Identifier: NCT01479933 |
Recruitment Status :
Completed
First Posted : November 28, 2011
Last Update Posted : March 5, 2013
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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.
Condition or disease | Intervention/treatment | Phase |
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Prediabetic State Overweight Obese | Dietary Supplement: Vitamin D3 Dietary Supplement: Placebo Dietary Supplement: Vitamin D 80 | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 73 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Basic Science |
Official Title: | Randomized Controlled Trial of Vitamin D Supplementation on Glucose Metabolism in Subjects With Components of the Metabolic Syndrome |
Study Start Date : | September 2011 |
Actual Primary Completion Date : | May 2012 |
Actual Study Completion Date : | May 2012 |

Arm | Intervention/treatment |
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Experimental: Vitamin D 40
Vitamin D3 40 micrograms (1600 IU) per day
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Dietary Supplement: Vitamin D3
Vitamin D3 40 micrograms (1600 IU) per day |
Experimental: Vitamin D 80
Vitamin D3 80 micrograms (3200 IU) per day
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Dietary Supplement: Vitamin D 80
Vitamin D3 80 micrograms (3200 IU) per day |
Placebo Comparator: Placebo |
Dietary Supplement: Placebo
Inactive placebo |
- Insulin sensitivity [ Time Frame: Six months ]Change in insulin sensitivity measured by oral glucose tolerance test at baseline and after 6 months
- Peripheral blood mononuclear cell gene expression [ Time Frame: Six months ]
- Inflammation [ Time Frame: Baseline to six months ]Change in inflammation measured as serum cytokines and adipose tissue inflammation at baseline and after 6 months
- Adipose tissue gene expression [ Time Frame: Six months ]

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Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 60 years or older
- Serum calcidiol <75 nmol/L
- Body mass index 25-35 kg/m2
- Impaired fasting glucose or impaired glucose tolerance (fasting glucose 5.6-7.0 mmol/L or 2h oral glucose tolerance test glucose 7.8-11.0 mmol/L)
Exclusion Criteria:
- Any chronic disease and condition, which may hamper to follow the intervention protocol (such as alcohol abuse)
- Any chronic disease or therapy which may mask or interact with the investigated effects (such as diabetes or systemic corticosteroid therapy)
- Any disease or state that raises a vitamin D related safety concern (such as chronic liver, thyroid or kidney disease, hypercalcemia, sarcoidosis or other granulomatous diseases such as active chronic tuberculosis or Wegener's granulomatosis)
- Use of supplements yielding vitamin D over 20 µg/d and unwillingness to discontinue the use.

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): NCT01479933
Finland | |
University of Eastern Finland, Kuopio Campus | |
Kuopio, Finland, 70211 |
Principal Investigator: | Tomi-Pekka Tuomainen, MD, PhD | University of Eastern Finland |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Tomi-Pekka Tuomainen, Professor, University of Eastern Finland |
ClinicalTrials.gov Identifier: | NCT01479933 |
Other Study ID Numbers: |
VitDmet |
First Posted: | November 28, 2011 Key Record Dates |
Last Update Posted: | March 5, 2013 |
Last Verified: | March 2013 |
vitamin D cholecalciferol supplementation prediabetic state obesity glucose metabolism |
gene expression transcriptomics epigenomics immunological function insulin sensitivity peripheral mononuclear cells |
Prediabetic State Overweight Body Weight Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Vitamin D Ergocalciferols |
Cholecalciferol Vitamins Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents |