Vitamin D Supplementation to Patients With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

Vitamin D Supplementation to Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00400491
• Other study ID #: EUDRACT-2006-000177-30
• Status: Completed
• Phase: Phase 2
• First received: November 16, 2006
• Last updated: May 22, 2008
• Start date: June 2006
• Est. completion date: September 2007

Study information

• Verified date: May 2008
• Source: University of Tromso
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Cholecalciferol (vitamin D)
Cholecalciferol capsule 20.000 IU twice per week for 6 months
• Placebo
Placebo capsule twice a week, identical to the cholecalciferol capsules

Locations

Country	Name	City	State
Norway	Clinical Research Unit, University Hospital of North Norway	Tromsø

Sponsors (1)

Lead Sponsor	Collaborator
University of Tromso

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glycated hemoglobin		6 months	No
Secondary	blood pressure		6 months	No
Secondary	body weight		6 months	No
Secondary	Hip/waist ratio		6 months	No
Secondary	lipids		6 months	No
Secondary	Hs-CRP		6 months	No
Secondary	insulin sensitivity		6 months	No