Vitamin D Supplementation to Patients With Type 2 Diabetes

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00400491

Enrollment

Registered

2006-11-17

Start date

2006-06-30

Completion date

2007-09-30

Last updated

2008-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

diabetes, insulin, glycated hemoglobin, cholecalciferol, vitamin D

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.

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.

Interventions

DRUGCholecalciferol (vitamin D)

Cholecalciferol capsule 20.000 IU twice per week for 6 months

DRUGPlacebo

Placebo capsule twice a week, identical to the cholecalciferol capsules

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
glycated hemoglobin	6 months

Secondary

Measure	Time frame
lipids	6 months
Hs-CRP	6 months
Hip/waist ratio	6 months
blood pressure	6 months
body weight	6 months
insulin sensitivity	6 months

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026