NCT00400491

Brief Summary

The purpose of the study is to evaluate if supplementation with vitamin D in a dose of 40.000 IU per week will result in improved metabolic control in patients with type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 type-2-diabetes

Timeline
Completed

Started Jun 2006

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

June 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 17, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

May 23, 2008

Status Verified

May 1, 2008

Enrollment Period

1.2 years

First QC Date

November 16, 2006

Last Update Submit

May 22, 2008

Conditions

Type 2 Diabetes

Keywords

diabetesinsulinglycated hemoglobincholecalciferolvitamin D

Outcome Measures

Primary Outcomes (1)

  • glycated hemoglobin

    6 months

Secondary Outcomes (6)

  • blood pressure

    6 months

  • body weight

    6 months

  • Hip/waist ratio

    6 months

  • lipids

    6 months

  • Hs-CRP

    6 months

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL
Drug: Cholecalciferol (vitamin D)

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Cholecalciferol (vitamin D)DRUG

Cholecalciferol capsule 20.000 IU twice per week for 6 months

Also known as: vitamin D
1
PlaceboDRUG

Placebo capsule twice a week, identical to the cholecalciferol capsules

2

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes for at least 1 year
  • age 21-75 years
  • long-acting insulin at bedtime
  • metformin during the day
  • for women of child bearing age use of reliable method of birth control

You may not qualify if:

  • serum creatinine above 130 umol/l for men and above 110 for women
  • systolic blood pressure \> 175 or diastolic \> 104 mmHg
  • heart disease
  • serum calcium \> 2.54 mmol/l
  • history of renal stones

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Unit, University Hospital of North Norway

Tromsø, Tromsø, 9038, Norway

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusInsulin Resistance

Interventions

CholecalciferolVitamin D

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsSecosteroidsMembrane LipidsLipids

Study Officials

  • Rolf Jorde, Professor

    University of Tromsø, Tromsø

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 16, 2006

First Posted

November 17, 2006

Study Start

June 1, 2006

Primary Completion

August 1, 2007

Study Completion

September 1, 2007

Last Updated

May 23, 2008

Record last verified: 2008-05

Locations

NO(1)