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Vitamin D AND Glucose Handling Evaluated by Glucose Clamp (D-clamp)

This study has been completed.
Sponsor:
Collaborator:
Norwegian Council on Cardiovascular diseases
Information provided by (Responsible Party):
University Hospital of North Norway
ClinicalTrials.gov Identifier:
NCT00809744
First received: December 16, 2008
Last updated: November 2, 2011
Last verified: November 2011
History of Changes
  Purpose

In this study the investigators want to compare glucose handling (insulin secretion and insulin sensitivity) in 100 persons with low and 50 persons with normal-high levels of vitamin D, using a hyperglycemic clamp technique, were sugar is given intravenously for 3 hours in order to keep the blood sugar level at 10 mmol/L. Those with low vitamin D levels will be randomized to treatment with vitamin D3 (cholecalciferol) 40 000 IU/week or placebo for 6 months before a new clamp is performed.

The study hypothesis is that persons with low vitamin D levels have impaired glucose handling which might be improved by vitamin D supplementation.


Condition Intervention Phase
Insulin Sensitivity
Intraocular Pressure
 Drug: cholecalciferol
 Phase 2

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: Vitamin D AND Cardiovascular Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:
  • insulin secretion and sensitivity as assessed by an hyperglycemic clamp [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • intraocular pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • telomer length [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D-levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • serum calcium, PTH, phosphate [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • inflammatory markers and lipids [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 160
Study Start Date: November 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: cholecalciferol
    capsules, 20 000IU, twice a week, 6 months duration
  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • generally: Subjects are recruited from the 6th Tromsø Study
  • cases: serum 25-hydroxyvitamin D-levels below the 10 percentile; low levels confirmed with new serum analyses.
  • controls: serum 25-hydroxyvitamin D levels 80-95 percentile, normal-high levels confirmed with new serum analyses.

Exclusion Criteria:

  • diabetes
  • myocardial infarction or apoplexia
  • active cancer during last 5 years
  • history of kidney stone
  • pregnancy or premenopausal without safe anticonception
  • primary hyperparathyroidism
  • systolic blood pressure >175 or diastolic blood pressure >105
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00809744

Locations
Norway
University Hospital of North Norway
Tromsø, Norway, 9037
Sponsors and Collaborators
University Hospital of North Norway
Norwegian Council on Cardiovascular diseases
Investigators
Principal Investigator: Rolf Jorde, Professor Medical Dpt, University Hospital of Northern Norway
  More Information

No publications provided by University Hospital of North Norway

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT00809744     History of Changes
Other Study ID Numbers: UIT-ENDO-2008-GURI-2
Study First Received: December 16, 2008
Last Updated: November 2, 2011
Health Authority: Norway: Norwegian Medicines Agency
Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services
Norway: Directorate of Health

Additional relevant MeSH terms:
Cardiovascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Cholecalciferol
Vitamin D
 Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 16, 2013