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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by University Hospital, Aker.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Oslo
Information provided by:
University Hospital, Aker
ClinicalTrials.gov Identifier:
NCT00992797
First received: October 5, 2009
Last updated: November 2, 2009
Last verified: November 2009
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus Type 2
Hypovitaminosis D
Drug: Cholecalciferol
Other: Orange juice
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 .

Resource links provided by NLM:


Further study details as provided by University Hospital, Aker:

Primary Outcome Measures:
  • Insulin sensitivity measured with euglycemic, hyperinsulinemic clamp [ Time Frame: Before and after the 6 months intervention period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Insulin secretion measured with IVGTT [ Time Frame: At 0 and 6 months ] [ Designated as safety issue: No ]
  • Physical activity/muscle strength [ Time Frame: At 0 and 6 months ] [ Designated as safety issue: No ]
  • HbA1c and fasting glucose [ Time Frame: At 0, 3 and 6 months ] [ Designated as safety issue: No ]
  • Arterial stiffness [ Time Frame: At 0 and 6 months ] [ Designated as safety issue: No ]
  • Differences in inflammatory markers, endothelial function and bone specific laboratory markers. [ Time Frame: At 0, 3 and 6 months ] [ Designated as safety issue: No ]
  • Safety of this regimen of vitamin D3 supplementation; subjects will be assessed for hypercalcemia and renal dysfunction. [ Time Frame: Entire intervention period, samples taken at 0,1,3, and 6 months ] [ Designated as safety issue: Yes ]
  • Change from baseline in quality of life score between groups (SF-36). [ Time Frame: At 0 and 6 months ] [ Designated as safety issue: No ]
  • Effect on serum lipid levels and other biochemical markers [ Time Frame: At 0, 3 and 6 months ] [ Designated as safety issue: No ]
  • Metabolomics analyses. [ Time Frame: At 0 and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cholecalciferol 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 Names:
  • Vitamin D
  • ZymaD
Placebo Comparator: Placebo Other: Orange juice
Orange juice at randomization day and at week 5.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00992797

Contacts
Contact: Gulseth Wium, MD 4722894745 diabeteslab@aus.no

Locations
Norway
Diabetes Laboratory, Oslo University Hospital Aker Recruiting
Oslo, Norway, 0514
Contact    4722894745    diabeteslab@aus.no   
Principal Investigator: Kåre I Birkeland, MD PhD         
Sponsors and Collaborators
University Hospital, Aker
University of Oslo
Investigators
Principal Investigator: Kåre I Birkeland, MD PhD Oslo University Hospital, Aker
  More Information

No publications provided

Responsible Party: Director of Research Tomm Bernklev, Oslo University Hospital, Aker
ClinicalTrials.gov Identifier: NCT00992797     History of Changes
Other Study ID Numbers: AUS-KIB-001
Study First Received: October 5, 2009
Last Updated: November 2, 2009
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by University Hospital, Aker:
Insulin resistance
Insulin secretory dysfunction
Inflammation
Vascular stiffness

Additional relevant MeSH terms:
Avitaminosis
Diabetes Mellitus
Diabetes Mellitus, Type 2
Rickets
Vitamin D Deficiency
Bone Diseases
Bone Diseases, Metabolic
Calcium Metabolism Disorders
Deficiency Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Malnutrition
Metabolic Diseases
Musculoskeletal Diseases
Nutrition Disorders
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014