Glucose Metabolism Effects of Vitamin D Supplementation in Prediabetes (VitDmet)
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Purpose
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 | Intervention |
|---|---|
|
Prediabetic State Overweight Obese |
Dietary Supplement: Vitamin D3 Dietary Supplement: Placebo Dietary Supplement: Vitamin D 80 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
- Insulin sensitivity [ Time Frame: Six months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Inflammation [ Time Frame: Baseline to six months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
| Enrollment: | 73 |
| Study Start Date: | September 2011 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Vitamin D 40
Vitamin D3 40 micrograms (1600 IU) per day
|
Dietary Supplement: Vitamin D3
Vitamin D3 40 micrograms (1600 IU) per day
|
|
Experimental: Vitamin D 80
Vitamin D3 80 micrograms (3200 IU) per day
|
Dietary Supplement: Vitamin D 80
Vitamin D3 80 micrograms (3200 IU) per day
|
| Placebo Comparator: Placebo |
Dietary Supplement: Placebo
Inactive placebo
|
Eligibility| Ages Eligible for Study: | 60 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01479933
| Finland | |
| University of Eastern Finland, Kuopio Campus | |
| Kuopio, Finland, 70211 | |
| Principal Investigator: | Tomi-Pekka Tuomainen, MD, PhD | University of Eastern Finland |
More Information
Additional Information:
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 History of Changes |
| Other Study ID Numbers: | VitDmet |
| Study First Received: | August 29, 2011 |
| Last Updated: | March 3, 2013 |
| Health Authority: | Finland: Ethics Committee |
Keywords provided by University of Eastern Finland:
|
vitamin D cholecalciferol supplementation prediabetic state obesity glucose metabolism |
gene expression transcriptomics epigenomics immunological function insulin sensitivity peripheral mononuclear cells |
Additional relevant MeSH terms:
|
Overweight Prediabetic State Body Weight Signs and Symptoms Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Vitamins Vitamin D Ergocalciferols Cholecalciferol Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on September 23, 2016