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Vitamin D is a hormone with effects not only on the skeleton, but on most tissues in the body. Lack of vitamin D is associated with cardio-vascular disease (CVD), type 2 diabetes, cancer, infectious and immunological diseases, as well as risk factors for these diseases. However, intervention studies with vitamin D have been inconclusive regarding diseases and risk factors. This could be due to inclusion of subjects already vitamin D sufficient, and short and underpowered studies. In addition, there are indications that the dosing regimens may be important, so that daily doses with vitamin D are more efficient than intermittent doses, which so far have been generally used. This could be related to the concentration of circulating and thereby intracellular vitamin D concentrations, which probably is dependent on daily vitamin D doses. This will be tested in the present study where 60 subjects will be randomized to vitamin D 160 000 once, vitamin D 4000 IU/day, or placebo for four weeks. The primary endpoints will be effects on serum hepcidin and plasma cathelicidin after 4 weeks, with effects on serum PTH, RNA expression and microRNA in peripheral blood, telomerase activity in peripheral blood mononuclear cells and the ration between serum 1,25(OH)2D and 24,25(OH)2D as secondary endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vitamin D bolus | Experimental | vitamin D 160 000 IU given as bolus |
|
| vitamin D daily | Experimental | vitamin D 4000 IU daily for 28 days |
|
| placebo | Placebo Comparator | identical looking as vitamin d |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Drug | vitamin D given as bolus versus daily dosing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hepcidin change | Difference between vitamin D given as a bolus 160 000IU vs 4000 IU regarding change in serum hepcidin | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in serum PTH after 1 month | Difference between vitamin D given as a bolus 160 000IU vs 4000 IU regarding change in serum PTH, cathelicidin, RNA expression and micro RNA in peripheral blood, telomerase activity and the ratio between 1,25(OH)2D and 24,25(OH)2D, after 1 month | 4 weeks |
| Difference in micro RNA Expression after 1 month |
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Inclusion Criteria:- Males and females 20 - 70 years
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| rolf jorde, MD PhD | UiT, Tromsø | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of North Norway | Tromsø | 9038 | Norway |
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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 |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Placebo | Drug | identical looking as vitamin D |
|
Difference between vitamin D given as a bolus 160 000IU vs 4000 IU |
| 4 weeks |
| Difference in serum cathelicidin after 1 month | Difference between vitamin D given as a bolus 160 000IU vs 4000 IU | 4 weeks |
| Difference in RNA Expression after 1 month | Difference between vitamin D given as a bolus 160 000IU vs 4000 IU | 4 weeks |
| Difference in telomerase Activity after 1 month | Difference between vitamin D given as a bolus 160 000IU vs 4000 IU | 4 weeks |
| Difference in ratio between 1,24(OH)2D and 24,24(OH)2D after 1 month | Difference between vitamin D given as a bolus 160 000IU vs 4000 IU | 4 weeks |
| D009750 |
| Nutritional and Metabolic Diseases |