Diabetes Intervention Trial With Vitamin D in Subjects of Nordic and Sub-Indian Ethnicity

Phase 2

• Conditions: Diabetes Mellitus Type 2; Hypovitaminosis D
• Interventions: Other: Orange juice; Drug: Cholecalciferol

• Registration Number: NCT00992797
• Lead Sponsor: University Hospital, Aker

Brief Summary

The aim of this 6 months study is to evaluate the metabolic effects of 400.000-600.000 IU of vitamin D supplementation in subjects with type 2 diabetes and hypovitaminosis D. The main hypothesis is that subjects with low levels of 25-OH-vitamin D will benefit from supplementation with cholecalciferol in sufficient doses to optimize serum levels.

Detailed Description

Accumulating evidence suggests that hypovitaminosis D may be associated with the development of type 2 diabetes and disturbances in glucose and insulin metabolism. There is lack of data from randomized, controlled studies of sufficient duration and with the use of sufficient doses of vitamin D to assess the importance of vitamin D supplementation in glucose metabolism in type 2 diabetes.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-10-05
• Study First Submitted QC: 2009-10-08
• Study First Posted: 2009-10-09
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-02
• Last Update Posted: 2009-11-03
• Primary Completion: 2010-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

1. Subjects not having type 2 diabetes.
2. SBP ≥ 160 or DBP ≥ 95 at Visit 1.
3. Significant renal disease or chronic renal impairment, GFR< 30 ml/min.
4. Significant liver disease or ASAT or ALAT >3x UNL.
5. Malignancy during the last five years.
6. Hypercalcemia at Visit 1.
7. A history of kidney stone disease
8. WOCBP unwilling or unable to use an acceptable method to avoid pregnancy.
9. Pregnant or breastfeeding women.
10. Chronic inflammatory disease in active phase
11. Long term (>2 weeks) use of corticosteroids last 3 months
12. Mental condition (psychiatric or organic cerebral disease) rendering the subject unable to understand the nature, scope and possible consequences of the study.
13. Drug or alcohol abuse.
14. BMI > 45 kg/m2 or bariatric surgery (<5 years).
15. Anemia
16. Cardiovascular disease (myocardial infarction, unstable angina pectoris or stroke) during the last 6 months.
17. Any medical condition that in the judgment of the investigator would jeopardize the subject's safety or evaluation of the study drug for efficacy and safety.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Orange juice	-
Cholecalciferol	Cholecalciferol	-

Primary Outcome Measures

Name	Time	Method
Insulin sensitivity measured with euglycemic, hyperinsulinemic clamp	Before and after the 6 months intervention period

Secondary Outcome Measures

Name	Time	Method
Insulin secretion measured with IVGTT	At 0 and 6 months
Physical activity/muscle strength	At 0 and 6 months
HbA1c and fasting glucose	At 0, 3 and 6 months
Arterial stiffness	At 0 and 6 months
Differences in inflammatory markers, endothelial function and bone specific laboratory markers.	At 0, 3 and 6 months
Safety of this regimen of vitamin D3 supplementation; subjects will be assessed for hypercalcemia and renal dysfunction.	Entire intervention period, samples taken at 0,1,3, and 6 months
Change from baseline in quality of life score between groups (SF-36).	At 0 and 6 months
Effect on serum lipid levels and other biochemical markers	At 0, 3 and 6 months
Metabolomics analyses.	At 0 and 6 months

Trial Locations

Locations (1)

Diabetes Laboratory, Oslo University Hospital Aker; 🇳🇴 Oslo, Norway