Efficacy and Safety of a Personalized Vitamin D[sub.3] 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] 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-hydroxy...

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Published inNutrients Vol. 14; no. 21
Main Authors Kuznia, Sabine, Czock, David, Kopp-Schneider, Annette, Caspari, Reiner, Fischer, Harald, Laetsch, Dana Clarissa, Slavic, Marija, Brenner, Hermann, Schöttker, Ben
Format Journal Article
LanguageEnglish
Published MDPI AG 01.10.2022
Subjects
Alfacalcidol
Calcifediol
Cancer patients
Care and treatment
Colorectal cancer
Diet therapy
Dietary supplements
Dosage and administration
Patient outcomes
Vitamin D
Vitamin D deficiency
Vitamin D3
Germany
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Summary:A personalized vitamin D[sub.3] 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] 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 (n = 5 in verum and n = 1 in the placebo group; p = 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] daily sustained the achieved levels.
ISSN:2072-6643
2072-6643
DOI:10.3390/nu14214546