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

Diabetes Mellitus Type 2 Clinical Trial

— DIVINE  

Official title:

A Randomized Controlled Trial of the Effect of Vitamin D Supplementation on Insulin Sensitivity and Secretion in Subjects With Type 2 Diabetes of Nordic and Sub-Indian Ethnicity .

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00992797
• Other study ID #: AUS-KIB-001
• Status: Recruiting
• Phase: Phase 2
• First received: October 5, 2009
• Last updated: November 2, 2009
• Start date: September 2009
• Est. completion date: December 2011

Study information

• Verified date: November 2009
• Source: University Hospital, Aker
• Contact: Gulseth Wium, MD
• Phone: 4722894745
• Email: diabeteslab[@]aus.no
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

1. Moderate (S-25OHD 25-50 nmol/l) to severe (S-25OHD < 25 nmol/l) vitamin D deficiency measured at Visit 1.

2. Patients with type 2 diabetes, including drug naïve subjects, subjects using oral anti-diabetic medication and subjects on insulin treatment. All medication must be in stable doses during the 4 week lead-in period.

3. HbA1c < 11 % at Visit 1.

4. Able to communicate in Norwegian.

5. Men and women = 18 years.

6. Norwegian or South Asian ethnicity.

7. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study. All WOCBP must have negative serum or urine pregnancy test at enrollment, randomization, titration visit and final study assessment.

8. Antihypertensive medication, lipid lowering drugs, oral contraceptives, hormone replacement therapy, multivitamin supplements and nutritional supplements are allowed if the subjects adhere to the same regimen during the study

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

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

• Avitaminosis
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2
• Hypovitaminosis D
• Rickets
• Vitamin D Deficiency

Intervention

Drug:
• Cholecalciferol
Cholecalciferol 200.000 IU pr ampoule, 400.000 IU given at randomization day, followed by additionally 200.000 IU at week 5 if serum 25(OH)D < 100 nmol/L. If serum 25(OH)D > 100 placebo will be given. The cholecalciferol will be given in orange juice.

Other:
• Orange juice
Orange juice at randomization day and at week 5.

Locations

Country	Name	City	State
Norway	Diabetes Laboratory, Oslo University Hospital Aker	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Aker	University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity measured with euglycemic, hyperinsulinemic clamp		Before and after the 6 months intervention period	No
Secondary	Insulin secretion measured with IVGTT		At 0 and 6 months	No
Secondary	Physical activity/muscle strength		At 0 and 6 months	No
Secondary	HbA1c and fasting glucose		At 0, 3 and 6 months	No
Secondary	Arterial stiffness		At 0 and 6 months	No
Secondary	Differences in inflammatory markers, endothelial function and bone specific laboratory markers.		At 0, 3 and 6 months	No
Secondary	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	Yes
Secondary	Change from baseline in quality of life score between groups (SF-36).		At 0 and 6 months	No
Secondary	Effect on serum lipid levels and other biochemical markers		At 0, 3 and 6 months	No
Secondary	Metabolomics analyses.		At 0 and 6 months	No