Vitamin D AND Glucose Handling Evaluated by Glucose Clamp | NCT00809744

Studies
Vitamin D AND Glucose Handling Evaluated by Glucose Clamp

NCT00809744

Sponsor

University Hospital of North Norway

Status

Completed

Last Update Posted

Nov 3, 2011Estimated

Enrollment

160Actual

Phase

Phase 2

Conditions

Insulin Sensitivity
Intraocular Pressure

Interventions

cholecalciferol

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Dec 16, 2008

First Submission Date that Met QC Criteria

Dec 16, 2008

First Posted Date

Dec 17, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 2, 2011

Last Update Posted Date

Nov 3, 2011Estimated

Name	Class
Norwegian Council on Cardiovascular diseases	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cholecalciferol	Drug	capsules, 20 000IU, twice a week, 6 months duration

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
insulin secretion and sensitivity as assessed by an hyperglycemic clamp		6 months
intraocular pressure		6 months

Secondary Outcomes

Measure	Description	Time Frame
telomer length		6 months
25-hydroxyvitamin D and 1,25-dihydroxyvitamin D-levels		6 months
serum calcium, PTH, phosphate

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rolf Jorde, Professor	Medical Dpt, University Hospital of Northern Norway	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of North Norway		Tromsø		9037	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21911741	Derived	Grimnes G, Figenschau Y, Almas B, Jorde R. Vitamin D, insulin secretion, sensitivity, and lipids: results from a case-control study and a randomized controlled trial using hyperglycemic clamp technique. Diabetes. 2011 Nov;60(11):2748-57. doi: 10.2337/db11-0650. Epub 2011 Sep 12.

ID	Term
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D002782	Cholestenes
D002776	Cholestanes
D013256	Steroids
D000072473	Fused-Ring Compounds