Vitamin D for the Prevention of Diabetes Type 2

NCT ID: NCT00685594

Last Updated: 2015-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 511 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2015-09-30

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.

Conditions

Impaired Glucose Tolerance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

1

Cholecalciferol 20.000 IU per week for 5 years

Group Type: EXPERIMENTAL

cholecalciferol

Intervention Type: DRUG

20.000 IU cholecalciferol per week for 5 years versus placebo

2

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo capsule once a week, identical to cholecalciferol capsule

Interventions

cholecalciferol

20.000 IU cholecalciferol per week for 5 years versus placebo

Intervention Type: DRUG

Placebo

Placebo capsule once a week, identical to cholecalciferol capsule

Intervention Type: DRUG

Other Intervention Names

vitamin D

Eligibility Criteria

Inclusion Criteria

• Impaired glucose tolerance

Exclusion Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital of North Norway

OTHER

Sponsor Role: collaborator

University of Tromso

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rolf Jorde, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Tromso

Locations

University of Tromso

Tromsø, , Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 26829443 (View on PubMed)

Other Identifiers

NFR 184766/V50

Identifier Type: -

Identifier Source: secondary_id

UIT-ENDO-2008-1

Identifier Type: -

Identifier Source: org_study_id