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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00992797
Recruitment Status : Unknown
Verified November 2009 by University Hospital, Aker.
Recruitment status was:  Recruiting
First Posted : October 9, 2009
Last Update Posted : November 3, 2009
University of Oslo
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Hypovitaminosis D Drug: Cholecalciferol Other: Orange juice Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 .
Study Start Date : September 2009
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2011

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Insulin sensitivity measured with euglycemic, hyperinsulinemic clamp [ Time Frame: Before and after the 6 months intervention period ]

Secondary Outcome Measures :
  1. Insulin secretion measured with IVGTT [ Time Frame: At 0 and 6 months ]
  2. Physical activity/muscle strength [ Time Frame: At 0 and 6 months ]
  3. HbA1c and fasting glucose [ Time Frame: At 0, 3 and 6 months ]
  4. Arterial stiffness [ Time Frame: At 0 and 6 months ]
  5. Differences in inflammatory markers, endothelial function and bone specific laboratory markers. [ Time Frame: At 0, 3 and 6 months ]
  6. 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 ]
  7. Change from baseline in quality of life score between groups (SF-36). [ Time Frame: At 0 and 6 months ]
  8. Effect on serum lipid levels and other biochemical markers [ Time Frame: At 0, 3 and 6 months ]
  9. Metabolomics analyses. [ Time Frame: At 0 and 6 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00992797

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Contact: Gulseth Wium, MD 4722894745

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Diabetes Laboratory, Oslo University Hospital Aker Recruiting
Oslo, Norway, 0514
Contact    4722894745   
Principal Investigator: Kåre I Birkeland, MD PhD         
Sponsors and Collaborators
University Hospital, Aker
University of Oslo
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Principal Investigator: Kåre I Birkeland, MD PhD Oslo University Hospital, Aker
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Director of Research Tomm Bernklev, Oslo University Hospital, Aker Identifier: NCT00992797    
Other Study ID Numbers: AUS-KIB-001
First Posted: October 9, 2009    Key Record Dates
Last Update Posted: November 3, 2009
Last Verified: November 2009
Keywords provided by University Hospital, Aker:
Insulin resistance
Insulin secretory dysfunction
Vascular stiffness
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Vitamin D Deficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Deficiency Diseases
Nutrition Disorders
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Calcium Metabolism Disorders
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents