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
Recruitment status was Recruiting
Sponsor:
University Hospital, Aker
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
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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:
|
| 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:
- Moderate (S-25OHD 25-50 nmol/l) to severe (S-25OHD < 25 nmol/l) vitamin D deficiency measured at Visit 1.
- 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.
- HbA1c < 11 % at Visit 1.
- Able to communicate in Norwegian.
- Men and women ≥ 18 years.
- Norwegian or South Asian ethnicity.
- 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.
- 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:
- Subjects not having type 2 diabetes.
- SBP ≥ 160 or DBP ≥ 95 at Visit 1.
- Significant renal disease or chronic renal impairment, GFR< 30 ml/min.
- Significant liver disease or ASAT or ALAT >3x UNL.
- Malignancy during the last five years.
- Hypercalcemia at Visit 1.
- A history of kidney stone disease
- WOCBP unwilling or unable to use an acceptable method to avoid pregnancy.
- Pregnant or breastfeeding women.
- Chronic inflammatory disease in active phase
- Long term (>2 weeks) use of corticosteroids last 3 months
- Mental condition (psychiatric or organic cerebral disease) rendering the subject unable to understand the nature, scope and possible consequences of the study.
- Drug or alcohol abuse.
- BMI > 45 kg/m2 or bariatric surgery (<5 years).
- Anemia
- Cardiovascular disease (myocardial infarction, unstable angina pectoris or stroke) during the last 6 months.
- 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
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:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Rickets Avitaminosis Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Calcium Metabolism Disorders Vitamin D Deficiency |
Deficiency Diseases Malnutrition Nutrition Disorders Cholecalciferol Vitamin D Ergocalciferols Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on May 16, 2013