A Phase 3 interventional study of Vitamin D and Placebo in Hypovitaminosis D, sponsored by University of Tromso. Completed at 1 site in Norway. Open to participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-24.
Sponsored by University of Tromso · Phase 3, Interventional, and Prevention
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.
Inclusion Criteria:- Males and females 20 - 70 years
Exclusion Criteria:
vitamin D 160 000 IU given as bolus
Drug: Vitamin D
vitamin D 4000 IU daily for 28 days
Drug: Vitamin D
identical looking as vitamin d
Drug: Placebo
vitamin D given as bolus versus daily dosing
identical looking as vitamin D
Hepcidin change
Difference between vitamin D given as a bolus 160 000IU vs 4000 IU regarding change in serum hepcidin
Time frame: 4 weeks
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
Time frame: 4 weeks
Difference in micro RNA Expression after 1 month
Difference between vitamin D given as a bolus 160 000IU vs 4000 IU
Time frame: 4 weeks
Difference in serum cathelicidin after 1 month
Difference between vitamin D given as a bolus 160 000IU vs 4000 IU
Time frame: 4 weeks
Difference in RNA Expression after 1 month
Difference between vitamin D given as a bolus 160 000IU vs 4000 IU
Time frame: 4 weeks
Difference in telomerase Activity after 1 month
Difference between vitamin D given as a bolus 160 000IU vs 4000 IU
Time frame: 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
Time frame: 4 weeks
Plan to share: No
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University of Tromso