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Completed

NCT Number: NCT00400491

Vitamin D Supplementation to Patients With Type 2 Diabetes

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Research Unit, University Hospital of North Norway

Tromsø, 9038, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecalciferol (vitamin D)

Drug

Cholecalciferol capsule 20.000 IU twice per week for 6 months

Other names: vitamin D

Placebo

Drug

Placebo capsule twice a week, identical to the cholecalciferol capsules

Primary outcomes

  1. glycated hemoglobin

    Time frame: 6 months

Secondary outcomes

  1. blood pressure

    Time frame: 6 months

  2. body weight

    Time frame: 6 months

  3. Hip/waist ratio

    Time frame: 6 months

  4. lipids

    Time frame: 6 months

  5. Hs-CRP

    Time frame: 6 months

  6. insulin sensitivity

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Tromso

Other

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Nov 17, 2006
Registry last updated
May 23, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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