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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
Sponsor:
Collaborators:
Academy of Finland
Juho Vainio Foundation
Finnish Foundation for Cardiovascular Research
Diabetes Research Foundation, Finland
Information provided by (Responsible Party):
Tomi-Pekka Tuomainen, University of Eastern Finland

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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
Prediabetic State Overweight Obese Dietary Supplement: Vitamin D3 Dietary Supplement: Placebo Dietary Supplement: Vitamin D 80 Not Applicable

Study Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Insulin sensitivity [ Time Frame: Six months ]
    Change in insulin sensitivity measured by oral glucose tolerance test at baseline and after 6 months


Secondary Outcome Measures :
  1. Peripheral blood mononuclear cell gene expression [ Time Frame: Six months ]
  2. Inflammation [ Time Frame: Baseline to six months ]
    Change in inflammation measured as serum cytokines and adipose tissue inflammation at baseline and after 6 months

  3. Adipose tissue gene expression [ Time Frame: Six months ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Finland
University of Eastern Finland, Kuopio Campus
Kuopio, Finland, 70211
Sponsors and Collaborators
University of Eastern Finland
Academy of Finland
Juho Vainio Foundation
Finnish Foundation for Cardiovascular Research
Diabetes Research Foundation, Finland
Investigators
Principal Investigator: Tomi-Pekka Tuomainen, MD, PhD University of Eastern Finland
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
University of Eastern Finland  This link exits the ClinicalTrials.gov site

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
First Posted: November 28, 2011    Key Record Dates
Last Update Posted: March 5, 2013
Last Verified: March 2013

Keywords provided by Tomi-Pekka Tuomainen, 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