Glucose Metabolism Effects of Vitamin D Supplementation in Prediabetes

NCT01479933 | Completed

• 1 other identifier: VitDmet
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Prediabetic State; Overweight; Obese

Keywords

vitamin D; cholecalciferol; supplementation; prediabetic state; obesity; glucose metabolism; gene expression; transcriptomics; epigenomics; immunological function; insulin sensitivity; peripheral mononuclear cells

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity

  Change in insulin sensitivity measured by oral glucose tolerance test at baseline and after 6 months

  Six months

Secondary Outcomes (3)

• Peripheral blood mononuclear cell gene expression

  Six months

• Inflammation

  Baseline to six months

• Adipose tissue gene expression

  Six months

Study Arms (3)

Vitamin D 40

EXPERIMENTAL

Vitamin D3 40 micrograms (1600 IU) per day

Dietary Supplement: Vitamin D3

Vitamin D 80

EXPERIMENTAL

Vitamin D3 80 micrograms (3200 IU) per day

Dietary Supplement: Vitamin D 80

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

Vitamin D3 40 micrograms (1600 IU) per day

Vitamin D 40

Placebo DIETARY_SUPPLEMENT

Inactive placebo

Placebo

Vitamin D 80 DIETARY_SUPPLEMENT

Vitamin D3 80 micrograms (3200 IU) per day

Vitamin D 80

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Eastern Finland: lead
• Academy of Finland: collaborator
• Juho Vainio Foundation: collaborator
• Finnish Foundation for Cardiovascular Research: collaborator
• Diabetes Research Foundation, Finland: collaborator

Study Sites (1)

University of Eastern Finland, Kuopio Campus

Kuopio, Kuopio, 70211, Finland

Location

Related Publications (1)

• 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.

  PMID: 24975273 DERIVED

Related Links

• University of Eastern Finland

MeSH Terms

Conditions

Prediabetic State; Overweight; Obesity; Insulin Resistance

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Tomi-Pekka Tuomainen, MD, PhD

  University of Eastern Finland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 29, 2011
• First Posted: November 28, 2011
• Study Start: September 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: March 5, 2013

Record last verified: 2013-03

Locations

FI (1)