Overview

Vitamin D AND Glucose Handling Evaluated by Glucose Clamp

Status:
Completed
Trial end date:
2010-12-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Hospital of North Norway
Collaborator:
Norwegian Council on Cardiovascular diseases
Treatments:
Cholecalciferol
Vitamin D
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