Efficacy and Safety of a Personalized Vitamin D<sub>3</sub> Loading Dose Followed by Daily 2000 IU in Colorectal Cancer Patients with Vitamin D Insufficiency: Interim Analysis of a Randomized Controlled Trial
A personalized vitamin D<sub>3</sub> loading dose has not yet been tested in cancer patients. This interim analysis of the randomized, placebo-controlled VICTORIA trial analyzed the first recruited 74 German adults with nonmetastatic colorectal cancer, a tumor surgery within the past yea...
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MDPI AG
2022-10-01
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| Series: | Nutrients |
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| Online Access: | https://www.mdpi.com/2072-6643/14/21/4546 |
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| author | Sabine Kuznia David Czock Annette Kopp-Schneider Reiner Caspari Harald Fischer Dana Clarissa Laetsch Marija Slavic Hermann Brenner Ben Schöttker |
| author_facet | Sabine Kuznia David Czock Annette Kopp-Schneider Reiner Caspari Harald Fischer Dana Clarissa Laetsch Marija Slavic Hermann Brenner Ben Schöttker |
| author_sort | Sabine Kuznia |
| collection | DOAJ |
| description | A personalized vitamin D<sub>3</sub> loading dose has not yet been tested in cancer patients. This interim analysis of the randomized, placebo-controlled VICTORIA trial analyzed the first recruited 74 German adults with nonmetastatic colorectal cancer, a tumor surgery within the past year, and 25-hydroxyvitamin D levels (25(OH)D) < 50 nmol/L. Study participants received a loading dose tailored for a baseline 25(OH)D level and BMI in the first 11 days, followed by a maintenance dose of 2000 IU of vitamin D<sub>3</sub> daily until end of trial week 12. The mean 25(OH)D levels were 27.6, 31.0, and 34.1 nmol/L in the placebo group and 25.9, 63.1, and 75.5 nmol/L in the verum group during screening, visit 1 (end of loading dose), and visit 2 (end of maintenance dose), respectively. The prevalence of 25(OH)D) ≥ 50 nmol/L at visits 1 and 2 was 3.5% and 17.4% in the placebo group and 80.0% and 100% in the verum group. No events of 25(OH)D > 150 nmol/L or hypercalcemia were observed. Hypercalciuria events at visit 1 (<i>n</i> = 5 in verum and <i>n</i> = 1 in the placebo group; <i>p</i> = 0.209) receded after discontinuation of the study medication. The personalized loading dose effectively and safely increased the 25(OH)D levels, and 2000 IU of vitamin D<sub>3</sub> daily sustained the achieved levels. |
| first_indexed | 2024-03-09T18:46:06Z |
| format | Article |
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| institution | Directory Open Access Journal |
| issn | 2072-6643 |
| language | English |
| last_indexed | 2024-03-09T18:46:06Z |
| publishDate | 2022-10-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Nutrients |
| spelling | doaj.art-835cb6dd73954dfd9d9fb5a75c27dc3d2023-11-24T06:13:17ZengMDPI AGNutrients2072-66432022-10-011421454610.3390/nu14214546Efficacy and Safety of a Personalized Vitamin D<sub>3</sub> Loading Dose Followed by Daily 2000 IU in Colorectal Cancer Patients with Vitamin D Insufficiency: Interim Analysis of a Randomized Controlled TrialSabine Kuznia0David Czock1Annette Kopp-Schneider2Reiner Caspari3Harald Fischer4Dana Clarissa Laetsch5Marija Slavic6Hermann Brenner7Ben Schöttker8Division of Clinical Epidemiology and Aging Research, German Cancer Research Center (DKFZ), 69120 Heidelberg, GermanyDepartment of Clinical Pharmacology and Pharmacoepidemiology, University Hospital Heidelberg, 69120 Heidelberg, GermanyDivision of Biostatistics, German Cancer Research Center (DKFZ), 69120 Heidelberg, GermanyClinic Niederrhein (A Clinic of the German Pension Insurance Rhineland), 53474 Bad Neuenahr-Ahrweiler, GermanyClinic Rosenberg (A Clinic of the German Pension Insurance Westfalen), 33014 Bad Driburg, GermanyDivision of Clinical Epidemiology and Aging Research, German Cancer Research Center (DKFZ), 69120 Heidelberg, GermanyDivision of Clinical Epidemiology and Aging Research, German Cancer Research Center (DKFZ), 69120 Heidelberg, GermanyDivision of Clinical Epidemiology and Aging Research, German Cancer Research Center (DKFZ), 69120 Heidelberg, GermanyDivision of Clinical Epidemiology and Aging Research, German Cancer Research Center (DKFZ), 69120 Heidelberg, GermanyA personalized vitamin D<sub>3</sub> loading dose has not yet been tested in cancer patients. This interim analysis of the randomized, placebo-controlled VICTORIA trial analyzed the first recruited 74 German adults with nonmetastatic colorectal cancer, a tumor surgery within the past year, and 25-hydroxyvitamin D levels (25(OH)D) < 50 nmol/L. Study participants received a loading dose tailored for a baseline 25(OH)D level and BMI in the first 11 days, followed by a maintenance dose of 2000 IU of vitamin D<sub>3</sub> daily until end of trial week 12. The mean 25(OH)D levels were 27.6, 31.0, and 34.1 nmol/L in the placebo group and 25.9, 63.1, and 75.5 nmol/L in the verum group during screening, visit 1 (end of loading dose), and visit 2 (end of maintenance dose), respectively. The prevalence of 25(OH)D) ≥ 50 nmol/L at visits 1 and 2 was 3.5% and 17.4% in the placebo group and 80.0% and 100% in the verum group. No events of 25(OH)D > 150 nmol/L or hypercalcemia were observed. Hypercalciuria events at visit 1 (<i>n</i> = 5 in verum and <i>n</i> = 1 in the placebo group; <i>p</i> = 0.209) receded after discontinuation of the study medication. The personalized loading dose effectively and safely increased the 25(OH)D levels, and 2000 IU of vitamin D<sub>3</sub> daily sustained the achieved levels.https://www.mdpi.com/2072-6643/14/21/4546vitamin Dcolorectal cancerrandomized controlled trialpersonalized medicineloading dosebolus |
| spellingShingle | Sabine Kuznia David Czock Annette Kopp-Schneider Reiner Caspari Harald Fischer Dana Clarissa Laetsch Marija Slavic Hermann Brenner Ben Schöttker Efficacy and Safety of a Personalized Vitamin D<sub>3</sub> Loading Dose Followed by Daily 2000 IU in Colorectal Cancer Patients with Vitamin D Insufficiency: Interim Analysis of a Randomized Controlled Trial Nutrients vitamin D colorectal cancer randomized controlled trial personalized medicine loading dose bolus |
| title | Efficacy and Safety of a Personalized Vitamin D<sub>3</sub> Loading Dose Followed by Daily 2000 IU in Colorectal Cancer Patients with Vitamin D Insufficiency: Interim Analysis of a Randomized Controlled Trial |
| title_full | Efficacy and Safety of a Personalized Vitamin D<sub>3</sub> Loading Dose Followed by Daily 2000 IU in Colorectal Cancer Patients with Vitamin D Insufficiency: Interim Analysis of a Randomized Controlled Trial |
| title_fullStr | Efficacy and Safety of a Personalized Vitamin D<sub>3</sub> Loading Dose Followed by Daily 2000 IU in Colorectal Cancer Patients with Vitamin D Insufficiency: Interim Analysis of a Randomized Controlled Trial |
| title_full_unstemmed | Efficacy and Safety of a Personalized Vitamin D<sub>3</sub> Loading Dose Followed by Daily 2000 IU in Colorectal Cancer Patients with Vitamin D Insufficiency: Interim Analysis of a Randomized Controlled Trial |
| title_short | Efficacy and Safety of a Personalized Vitamin D<sub>3</sub> Loading Dose Followed by Daily 2000 IU in Colorectal Cancer Patients with Vitamin D Insufficiency: Interim Analysis of a Randomized Controlled Trial |
| title_sort | efficacy and safety of a personalized vitamin d sub 3 sub loading dose followed by daily 2000 iu in colorectal cancer patients with vitamin d insufficiency interim analysis of a randomized controlled trial |
| topic | vitamin D colorectal cancer randomized controlled trial personalized medicine loading dose bolus |
| url | https://www.mdpi.com/2072-6643/14/21/4546 |
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