Trial | NCT00809744  Report issue

Title

Vitamin D AND Glucose Handling Evaluated by Glucose Clamp
Vitamin D AND Cardiovascular Disease

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    vitamin d3 ...

  • Study Participants

    160
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.
Study Started
Nov 30
2008
Primary Completion
Dec 31
2010
Study Completion
Dec 31
2010
Last Update
Nov 03
2011
Estimate

Drug cholecalciferol

capsules, 20 000IU, twice a week, 6 months duration

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
No Results Posted