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Vitamin D Supplementation to Patients With Type 2 Diabetes

Sponsor
University of Tromso (Other)
Overall Status
Completed
CT.gov ID
NCT00400491
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
15
Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Cholecalciferol (vitamin D)
  • Drug: Placebo
 Phase 2

Detailed Description

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.

We will include 70 patients with type 2 diabetes. They will be treated with 40.000 IU cholecalciferol per week (or placebo) for 6 months. Metabolic control will be evaluated with measurements of glycated hemoglobin, home glucose measurements, and fasting blod glucose and serum insulin. Only subjects using insulin at bedtime combined with metformin during the day will be included.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Vitamin D Supplementation to Patients With Type 2 Diabetes
Study Start Date :
Jun 1, 2006
Actual Primary Completion Date :
Aug 1, 2007
Actual Study Completion Date :
Sep 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Drug: Cholecalciferol (vitamin D)
Cholecalciferol capsule 20.000 IU twice per week for 6 months
Other Names:
  • vitamin D

    		•
    Placebo Comparator: 2

    Drug: Placebo
    Placebo capsule twice a week, identical to the cholecalciferol capsules

    Outcome Measures

    Primary Outcome Measures

    1. glycated hemoglobin [6 months]

    Secondary Outcome Measures

    1. blood pressure [6 months]

    2. body weight [6 months]

    3. Hip/waist ratio [6 months]

    4. lipids [6 months]

    5. Hs-CRP [6 months]

    6. insulin sensitivity [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Research Unit, University Hospital of North Norway Tromsø Norway 9038

    Sponsors and Collaborators

    • University of Tromso

    Investigators

    • Principal Investigator: Rolf Jorde, Professor, University of Tromsø, Tromsø

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00400491
    Other Study ID Numbers:
    • EUDRACT-2006-000177-30
    First Posted:
    Nov 17, 2006
    Last Update Posted:
    May 23, 2008
    Last Verified:
    May 1, 2008
    Keywords provided by , ,
    diabetes
    insulin
    glycated hemoglobin
    cholecalciferol
    vitamin D
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Vitamin D
    Ergocalciferols
    Cholecalciferol
    Vitamins

    Study Results

    No Results Posted as of May 23, 2008