Vitamin D AND Glucose Handling Evaluated by Glucose Clamp - Full Text View

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

This study is currently recruiting participants.

Verified by University Hospital of North Norway, December 2008

First Received: December 16, 2008 Last Updated: December 19, 2008 History of Changes

Sponsors and Collaborators:	University Hospital of North Norway Norwegian Council on Cardiovascular diseases
Information provided by:	University Hospital of North Norway
ClinicalTrials.gov Identifier:	NCT00809744

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 II

Drug Information available for: Cholecalciferol Vitamin D

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Vitamin D AND Cardiovascular Disease

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 ]

Estimated Enrollment:	150
Study Start Date:	November 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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

Contacts

Contact: Guri Grimnes, M.D	+47 776 26000	guri.grimnes@unn.no
Contact: Rolf Jorde, Professor	+47 776 26000	rolf.jorde@unn.no

Locations

Norway
University Hospital of North Norway	Recruiting
Tromsø, Norway, 9037
Contact: Guri Grimnes, M.D +47 776 26000 guri.grimnes@unn.no
Principal Investigator: Rolf Jorde, Professor

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

Responsible Party:	Medical Department, University Hospital of North Norway ( professor Rolf Jorde )
Study ID Numbers:	UIT-ENDO-2008-GURI-2
Study First Received:	December 16, 2008
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00809744 History of Changes
Health Authority:	Norway: Norwegian Medicines Agency; Norway: The National Committees for Research Ethics in Norway; Norway: Norwegian Social Science Data Services; Norway: Directorate for Health and Social Affairs

Study placed in the following topic categories:

Cholecalciferol
Vitamin D
Vitamins

Bone Density Conservation Agents
Trace Elements
Micronutrients

Additional relevant MeSH terms:

Cholecalciferol
Growth Substances
Vitamins
Physiological Effects of Drugs

Bone Density Conservation Agents
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009