The secondary outcome was overall survival time to death due to any cause. Main Outcomes and Measures The primary outcome was relapse-free survival time to relapse or death. Interventions Patients were randomized to receive oral supplemental capsules of vitamin D (2000 IU/d n = 251) or placebo (n = 166) from the first postoperative outpatient visit to until the end of the trial. Of 439 eligible patients, 15 declined and 7 were excluded after operation. Patients aged 30 to 90 years with cancers of the digestive tract from the esophagus to the rectum, stages I to III, were recruited. Enrollment began in January 2010 and follow-up was completed in February 2018.
Objective To determine whether postoperative vitamin D 3 supplementation can improve survival of patients with digestive tract cancers overall and in subgroups stratified by 25-hydroxyvitamin D (25D) levels.ĭesign, Setting, and Participants The AMATERASU trial, a randomized, double-blind, placebo-controlled trial conducted at a single university hospital in Japan. Importance Randomized clinical trials of vitamin D supplementation for secondary prevention in patients with cancer are needed, given positive results of observational studies.
Scientific Discovery and the Future of Medicine.Health Care Economics, Insurance, Payment.Clinical Implications of Basic Neuroscience.
Challenges in Clinical Electrocardiography.Median observation times for total deaths in the middle 25(OH)D subgroup were, for placebo, 3.5 (IQR, 2.3-5.0) years, and for vitamin D, 3.8 (IQR, 2.5-5.4) years and in the low 25(OH)D subgroup, for placebo, 3.4 (IQR, 2.1-5.0 years), and for vitamin D, 3.3 (IQR, 1.9-5.4) years. Median observation times for relapse or death in the middle 25(OH)D subgroup were, for placebo, 3.4 (interquartile range, 1.9-4.5) years, and for vitamin D, 3.8 (IQR, 2.4-5.3) years and in the low 25(OH)D subgroup, for placebo, 2.8 (IQR, 1.8-4.4) years, and for vitamin D, 2.5 (IQR, 1.6-5.2) years. Numbers at risk for panel C are not given because of weighting. Nelson-Aalen cumulative hazard curves are shown for relapse or death in the subgroups of (A) middle (20-40 ng/mL) and (B) low (40 ng/mL) 25(OH)D baseline levels this group was not evaluated.