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A randomized placebo controlled trial evaluating the effect of the recently recommended high doses of cholecalciferol (3000 IU/day) on mineral metabolism, blood pressure and pulse wave analysis in healthy individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cholecalciferol | Active Comparator | 3000 IU cholecalciferol per day for 16 weeks |
|
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cholecalciferol | Dietary Supplement | Capsule cholecalciferol 1000 IU, 3 capsules per day for 16 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| urinary calcium excretion | before and after 16 weeks of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 25 hydroxyvitamin D | before and after 16 weeks og treatment | |
| 1,25 dihydroxyvitamin D | before and after 16 weeks of treatment | |
| urinary creatinin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ditte Hansen, MD | Zealand University Hospital | Principal Investigator |
| Niels Erik Frandsen, MD | Zealand University Hospital | Principal Investigator |
| Knud Rasmussen, DmSci | Zealand University Hospital | Principal Investigator |
| Lisbet Brandi, DmSci | Zealand University Hospital | Principal Investigator |
| Hans Christian Hoeck, DmSci | Center for clinical and basic research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roskilde Hospital | Roskilde | Roskilde | 4000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27509187 | Derived | Bressendorff I, Brandi L, Schou M, Nygaard B, Frandsen NE, Rasmussen K, Odum L, Ostergaard OV, Hansen D. The Effect of High Dose Cholecalciferol on Arterial Stiffness and Peripheral and Central Blood Pressure in Healthy Humans: A Randomized Controlled Trial. PLoS One. 2016 Aug 10;11(8):e0160905. doi: 10.1371/journal.pone.0160905. eCollection 2016. | |
| 25166750 |
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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 | Dietary Supplement | Empty capsules, 3 capsules per day for 16 weeks |
|
| before and after 16 weeks of treatment |
| urinary protein | before and after 16 weeks of treatment |
| urinary phosphorous | before and after 16 weeks of treatment |
| p-FGF23 | before and after 16 weeks of treatment |
| blood pressure | before and after 16 weeks of treatment |
| pulse wave velocity | before and after 16 weeks of treatment |
| augmentation index | before and after 16 weeks of treatment |
| central blood pressure | before and after 16 weeks of treatment |
| p-phosphate | before and after 16 weeks of treatment |
| ionised p-calcium | before and after 16 weeks of treatment |
| p-iPTH | before and after 16 weeks of treatment |
| alkalic phosphatase | before and after 16 weeks of treatment |
| Nygaard B, Frandsen NE, Brandi L, Rasmussen K, Oestergaard OV, Oedum L, Hoeck HC, Hansen D. Effects of high doses of cholecalciferol in normal subjects: a randomized double-blinded, placebo-controlled trial. PLoS One. 2014 Aug 28;9(8):e102965. doi: 10.1371/journal.pone.0102965. eCollection 2014. |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |