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

U

University Hospital of North Norway

Status and phase

Completed
Phase 2

Conditions

Intraocular Pressure
Insulin Sensitivity

Treatments

Drug: cholecalciferol

Study type

Interventional

Funder types

Other

Identifiers

NCT00809744
UIT-ENDO-2008-GURI-2

Details and patient eligibility

About

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.

Enrollment

160 patients

Sex

All

Ages

30 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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