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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-018139-98 | EudraCT Number | ||
| KLnro 1/2010 | Other Identifier | The Finnish Medicines Agency Fimea |
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The purpose of this study is to determine if infrequent administration of oral vitamin D megadoses is effective treatment to maintain serum 25-hydroxyvitamin D(3) above target levels of 50-75 nmol/L. The investigators hypothesize that 100 000 IU or at least 200 000 IU vitamin D3 in every three months would be effective and safe treatment to achieve the target levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 200 000 IU vitamin D3 every three months | Experimental |
| |
| 100 000 IU vitamin D3 every three months | Experimental |
| |
| placebo every three months | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitamin D3 (cholecalciferol) | Dietary Supplement | vitamin D3 (cholecalciferol) oil 20 000 IU/ml, oral dose of 200 000 IU or 100 000 IU (10ml or 5ml) every three months for one year. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum 25(OH)D3 concentration in relation to the target levels of 50-75 nmol/L | 12 months (including 9 time points) |
| Measure | Description | Time Frame |
|---|---|---|
| Decline of creatine clearance (Pt-GFRe-CG) >20% from baseline | 12 months (including 9 timepoints) | |
| Hypercalciuria (dU-Ca >10 mmol/24h) | 12 months (including 9 timepoints) | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Endocrinology, Department of Medicine, Helsinki University Central Hospital | Helsinki | FI-00029 HUS | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19486025 | Background | Pekkarinen T, Valimaki VV, Aarum S, Turpeinen U, Hamalainen E, Loyttyniemi E, Valimaki MJ. The same annual dose of 292000 IU of vitamin D (cholecalciferol) on either daily or four monthly basis for elderly women: 1-year comparative study of the effects on serum 25(OH)D concentrations and renal function. Clin Endocrinol (Oxf). 2010 Apr;72(4):455-61. doi: 10.1111/j.1365-2265.2009.03637.x. Epub 2009 May 25. | |
| 17136043 |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D000069463 | Olive Oil |
| D002119 | Calcium Carbonate |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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|
| olive oil | Other | 10 ml (placebo group) or 5 ml (100 000 IU vitamin D3 group) oil per os every three months for one year |
|
| calcium carbonate | Dietary Supplement | 1000 mg calcium per os every day for one year |
|
| Hypercalcemia (S-Ca-ion >1,3 mmol/l) |
| 12 months (including 9 timepoints) |
| Serum PTH | 12 months (including 9 timepoints) |
| Serum PINP | 12 months (including 5 timepoints) |
| Serum CTX | 12 months (including 5 timepoints) |
| Background |
| Valimaki VV, Loyttyniemi E, Valimaki MJ. Vitamin D fortification of milk products does not resolve hypovitaminosis D in young Finnish men. Eur J Clin Nutr. 2007 Apr;61(4):493-7. doi: 10.1038/sj.ejcn.1602550. Epub 2006 Nov 29. |
| 14715830 | Background | Valimaki VV, Alfthan H, Lehmuskallio E, Loyttyniemi E, Sahi T, Stenman UH, Suominen H, Valimaki MJ. Vitamin D status as a determinant of peak bone mass in young Finnish men. J Clin Endocrinol Metab. 2004 Jan;89(1):76-80. doi: 10.1210/jc.2003-030817. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D008903 | Minerals |