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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-024487-18 | EudraCT Number |
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The purpose of this study is to evaluate if treatment with vitamin D increase beta cell function and insulin sensitivity in subjects with pre-diabetes or newly diagnosed diabetes mellitus type 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D3 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Drug | Oral drops 30000 IU weekly |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Beta cell function | Assessed by hyperglycemic clamp investigation | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin sensitivity | Assessed by hyperglycemic clamp investigation | 8 weeks |
| Glucose tolerance | Assessed by OGTT | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Treatment with any vitamin D preparation.
Regular sun-bathing in solarium.
Hypercalcemia at screening, defined as free s-calcium > 1.35 mmol/l.
Hyperphosphatemia at screening, defined as s-phosphate > 1.5 mmol/l.
Sarcoidosis or other granulomatous disease.
Treatment with phenytoin, barbiturates, rifampicin, isoniazid, cardiac glycosides, orlistat or colestyramin.
Impaired hepatic function.
Impaired renal function
Cardiac disease defined as:
Cerebral stroke within the last 6 months.
Anti-diabetic medication of any kind.
Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods.
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| Name | Affiliation | Role |
|---|---|---|
| Henrik Wagner, M.D | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dpt of Endocrinology, Karolinska University Hospital | Stockholm | Stockholm County | 17176 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26786573 | Derived | Wagner H, Alvarsson M, Mannheimer B, Degerblad M, Ostenson CG. No Effect of High-Dose Vitamin D Treatment on beta-Cell Function, Insulin Sensitivity, or Glucose Homeostasis in Subjects With Abnormal Glucose Tolerance: A Randomized Clinical Trial. Diabetes Care. 2016 Mar;39(3):345-52. doi: 10.2337/dc15-1057. Epub 2016 Jan 19. | |
| 25835492 |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D018149 | Glucose Intolerance |
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Placebo | Drug | Matching placebo |
|
| Hypercalcemia | 8 weeks |
| Mannheimer B, Wagner H, Ostenson CG, Diczfalusy U. No impact of vitamin D on the CYP3A biomarker 4beta-hydroxycholesterol in patients with abnormal glucose regulation. PLoS One. 2015 Apr 2;10(4):e0121984. doi: 10.1371/journal.pone.0121984. eCollection 2015. |
| D004700 | Endocrine System Diseases |
| D006943 | Hyperglycemia |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |