NCT00685594

Brief Summary

The prevalence of type 2 diabetes is increasing, which for most societies has considerable consequences not only regarding health but also economy. Type 2 diabetes develops through a "prediabetic" stage with impaired glucose tolerance. Intervention at this stage with change in lifestyle or with medication may prevent such progression. There are indications that vitamin D is of importance in glucose metabolism, and that supplementation with vitamin D may increase both insulin secretion and insulin sensitivity. Accordingly, supplementation with vitamin D may improve glucose tolerance and potentially prevent the development of type 2 diabetes in subjects at risk. However, this has so far not been demonstrated in a prospective, randomised clinical study. In the present study we will therefore include 600 subjects with impaired glucose tolerance (or impaired fasting glucose) detected in the Tromso study 2007/2008 and randomize to supplementation with vitamin D 20.000IU per week or placebo for 5 years. A glucose tolerance test will be performed each year, and development of type 2 diabetes will be the main endpoint.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
511

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2008

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2008

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 28, 2008

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 22, 2015

Status Verified

September 1, 2015

Enrollment Period

7 years

First QC Date

May 9, 2008

Last Update Submit

September 18, 2015

Conditions

Impaired Glucose Tolerance

Keywords

diabetesvitamin Dcholecalciferolglucose tolerance

Outcome Measures

Primary Outcomes (1)

  • development of diabetes type 2

    5 years

Secondary Outcomes (11)

  • change in glucose metabolism

    5 years

  • change in lipid status

    5 years

  • change in mood

    5 years

  • change in BMD hip

    5 years

  • change in intima media thickness carotid artery

    5 years

  • +6 more secondary outcomes

Other Outcomes (1)

  • Oral glucose tolerance response to vitamin D supplementation in relation to polymorphisms in the vitamin D system

    1 year

Study Arms (2)

1

EXPERIMENTAL

Cholecalciferol 20.000 IU per week for 5 years

Drug: cholecalciferol

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

cholecalciferolDRUG

20.000 IU cholecalciferol per week for 5 years versus placebo

Also known as: vitamin D
1
PlaceboDRUG

Placebo capsule once a week, identical to cholecalciferol capsule

2

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Impaired glucose tolerance

You may not qualify if:

  • Serious heart disease
  • Renal stone disease
  • Hypercalcemia
  • Sarcoidosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tromso

Tromsø, 9037, Norway

Location

Related Publications (1)

  • Jorde R, Sollid ST, Svartberg J, Schirmer H, Joakimsen RM, Njolstad I, Fuskevag OM, Figenschau Y, Hutchinson MY. Vitamin D 20,000 IU per Week for Five Years Does Not Prevent Progression From Prediabetes to Diabetes. J Clin Endocrinol Metab. 2016 Apr;101(4):1647-55. doi: 10.1210/jc.2015-4013. Epub 2016 Feb 1.

    PMID: 26829443DERIVED

MeSH Terms

Conditions

Glucose IntoleranceDiabetes Mellitus

Interventions

CholecalciferolVitamin D

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsSecosteroidsMembrane LipidsLipids

Study Officials

  • Rolf Jorde, Professor

    University of Tromso

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2008

First Posted

May 28, 2008

Study Start

March 1, 2008

Primary Completion

March 1, 2015

Study Completion

September 1, 2015

Last Updated

September 22, 2015

Record last verified: 2015-09

Locations

NO(1)