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...
Ausführliche Beschreibung
Autor*in: |
Sabine Kuznia [verfasserIn] David Czock [verfasserIn] Annette Kopp-Schneider [verfasserIn] Reiner Caspari [verfasserIn] Harald Fischer [verfasserIn] Dana Clarissa Laetsch [verfasserIn] Marija Slavic [verfasserIn] Hermann Brenner [verfasserIn] Ben Schöttker [verfasserIn] |
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E-Artikel |
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Sprache: |
Englisch |
Erschienen: |
2022 |
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Übergeordnetes Werk: |
In: Nutrients - MDPI AG, 2009, 14(2022), 21, p 4546 |
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Übergeordnetes Werk: |
volume:14 ; year:2022 ; number:21, p 4546 |
Links: |
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DOI / URN: |
10.3390/nu14214546 |
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Katalog-ID: |
DOAJ086474995 |
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10.3390/nu14214546 doi (DE-627)DOAJ086474995 (DE-599)DOAJ835cb6dd73954dfd9d9fb5a75c27dc3d DE-627 ger DE-627 rakwb eng TX341-641 Sabine Kuznia verfasserin aut 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 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. vitamin D colorectal cancer randomized controlled trial personalized medicine loading dose bolus Nutrition. Foods and food supply David Czock verfasserin aut Annette Kopp-Schneider verfasserin aut Reiner Caspari verfasserin aut Harald Fischer verfasserin aut Dana Clarissa Laetsch verfasserin aut Marija Slavic verfasserin aut Hermann Brenner verfasserin aut Ben Schöttker verfasserin aut In Nutrients MDPI AG, 2009 14(2022), 21, p 4546 (DE-627)610604155 (DE-600)2518386-2 20726643 nnns volume:14 year:2022 number:21, p 4546 https://doi.org/10.3390/nu14214546 kostenfrei https://doaj.org/article/835cb6dd73954dfd9d9fb5a75c27dc3d kostenfrei https://www.mdpi.com/2072-6643/14/21/4546 kostenfrei https://doaj.org/toc/2072-6643 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2022 21, p 4546 |
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10.3390/nu14214546 doi (DE-627)DOAJ086474995 (DE-599)DOAJ835cb6dd73954dfd9d9fb5a75c27dc3d DE-627 ger DE-627 rakwb eng TX341-641 Sabine Kuznia verfasserin aut 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 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. vitamin D colorectal cancer randomized controlled trial personalized medicine loading dose bolus Nutrition. Foods and food supply David Czock verfasserin aut Annette Kopp-Schneider verfasserin aut Reiner Caspari verfasserin aut Harald Fischer verfasserin aut Dana Clarissa Laetsch verfasserin aut Marija Slavic verfasserin aut Hermann Brenner verfasserin aut Ben Schöttker verfasserin aut In Nutrients MDPI AG, 2009 14(2022), 21, p 4546 (DE-627)610604155 (DE-600)2518386-2 20726643 nnns volume:14 year:2022 number:21, p 4546 https://doi.org/10.3390/nu14214546 kostenfrei https://doaj.org/article/835cb6dd73954dfd9d9fb5a75c27dc3d kostenfrei https://www.mdpi.com/2072-6643/14/21/4546 kostenfrei https://doaj.org/toc/2072-6643 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2022 21, p 4546 |
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10.3390/nu14214546 doi (DE-627)DOAJ086474995 (DE-599)DOAJ835cb6dd73954dfd9d9fb5a75c27dc3d DE-627 ger DE-627 rakwb eng TX341-641 Sabine Kuznia verfasserin aut 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 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. vitamin D colorectal cancer randomized controlled trial personalized medicine loading dose bolus Nutrition. Foods and food supply David Czock verfasserin aut Annette Kopp-Schneider verfasserin aut Reiner Caspari verfasserin aut Harald Fischer verfasserin aut Dana Clarissa Laetsch verfasserin aut Marija Slavic verfasserin aut Hermann Brenner verfasserin aut Ben Schöttker verfasserin aut In Nutrients MDPI AG, 2009 14(2022), 21, p 4546 (DE-627)610604155 (DE-600)2518386-2 20726643 nnns volume:14 year:2022 number:21, p 4546 https://doi.org/10.3390/nu14214546 kostenfrei https://doaj.org/article/835cb6dd73954dfd9d9fb5a75c27dc3d kostenfrei https://www.mdpi.com/2072-6643/14/21/4546 kostenfrei https://doaj.org/toc/2072-6643 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2022 21, p 4546 |
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10.3390/nu14214546 doi (DE-627)DOAJ086474995 (DE-599)DOAJ835cb6dd73954dfd9d9fb5a75c27dc3d DE-627 ger DE-627 rakwb eng TX341-641 Sabine Kuznia verfasserin aut 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 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. vitamin D colorectal cancer randomized controlled trial personalized medicine loading dose bolus Nutrition. Foods and food supply David Czock verfasserin aut Annette Kopp-Schneider verfasserin aut Reiner Caspari verfasserin aut Harald Fischer verfasserin aut Dana Clarissa Laetsch verfasserin aut Marija Slavic verfasserin aut Hermann Brenner verfasserin aut Ben Schöttker verfasserin aut In Nutrients MDPI AG, 2009 14(2022), 21, p 4546 (DE-627)610604155 (DE-600)2518386-2 20726643 nnns volume:14 year:2022 number:21, p 4546 https://doi.org/10.3390/nu14214546 kostenfrei https://doaj.org/article/835cb6dd73954dfd9d9fb5a75c27dc3d kostenfrei https://www.mdpi.com/2072-6643/14/21/4546 kostenfrei https://doaj.org/toc/2072-6643 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2022 21, p 4546 |
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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 |
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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. |
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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. |
abstract_unstemmed |
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. |
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21, p 4546 |
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 |
url |
https://doi.org/10.3390/nu14214546 https://doaj.org/article/835cb6dd73954dfd9d9fb5a75c27dc3d https://www.mdpi.com/2072-6643/14/21/4546 https://doaj.org/toc/2072-6643 |
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David Czock Annette Kopp-Schneider Reiner Caspari Harald Fischer Dana Clarissa Laetsch Marija Slavic Hermann Brenner Ben Schöttker |
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