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Vitamin D Supplementation to Patients With Type 2 Diabetes

U

University of Tromso (UiT)

Status and phase

Completed
Phase 2

Conditions

Type 2 Diabetes

Treatments

Drug: Placebo
Drug: Cholecalciferol (vitamin D)

Study type

Interventional

Funder types

Other

Identifiers

NCT00400491
EUDRACT-2006-000177-30

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

21 to 75 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

40 participants in 2 patient groups, including a placebo group

1
Experimental group
Treatment:
Drug: Cholecalciferol (vitamin D)
2
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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