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

NCT ID: NCT00992797

Last Updated: 2009-11-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-12-31

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.

Conditions

Diabetes Mellitus Type 2; Hypovitaminosis D

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cholecalciferol

Group Type: EXPERIMENTAL

Cholecalciferol

Intervention Type: DRUG

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.

Placebo

Group Type: PLACEBO_COMPARATOR

Orange juice

Intervention Type: OTHER

Orange juice at randomization day and at week 5.

Interventions

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.

Intervention Type: DRUG

Orange juice

Orange juice at randomization day and at week 5.

Intervention Type: OTHER

Other Intervention Names

Vitamin D; ZymaD

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oslo

OTHER

Sponsor Role: collaborator

University Hospital, Aker

OTHER

Sponsor Role: lead

Responsible Party

Oslo University Hospital, Aker

Principal Investigators

Kåre I Birkeland, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital, Aker

Locations

Diabetes Laboratory, Oslo University Hospital Aker

Oslo, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Gulseth Wium, MD

Role: CONTACT

diabeteslab@aus.no

4722894745

Facility Contacts

Role: primary

diabeteslab@aus.no

4722894745

References

Gulseth HL, Wium C, Angel K, Eriksen EF, Birkeland KI. Effects of Vitamin D Supplementation on Insulin Sensitivity and Insulin Secretion in Subjects With Type 2 Diabetes and Vitamin D Deficiency: A Randomized Controlled Trial. Diabetes Care. 2017 Jul;40(7):872-878. doi: 10.2337/dc16-2302. Epub 2017 May 3.

Reference Type: DERIVED

PMID: 28468770 (View on PubMed)

Other Identifiers

AUS-KIB-001

Identifier Type: -

Identifier Source: org_study_id