CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 70 target
Drug / intervention
cholecalciferoldietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02603757
NCT02603757N/ACompleted

Prospective Pilot Study to Assess the Effectiveness of Vitamin D Supplementation for Patients Requiring Chemotherapy for Stage III Colorectal Cancer

Legacy Health System·interventional·Posted Nov 13, 2015·Updated Oct 1, 2020

In Brief

A clinical study evaluating cholecalciferol for Colon Cancer and Rectal Cancer. Completed, enrolled 70 participants across 3 sites.

Detailed Summary

This is a pilot study to test whether there is an association between baseline Vitamin D levels, Vitamin D supplementation and survival in patients with stage III colon and stage II/III rectal cancer receiving chemotherapy. 70 patients with colon stage III or rectal stage II or III cancer that require chemotherapy will be screened and 60 patients will be enrolled. Patients will be randomized to standard dose (2000 IU daily) or high-dose (50,000 IU weekly) Vitamin D supplementation for 1 year after initiation of chemotherapy. Patients' Vitamin D levels will be checked throughout supplementation then followed for 5 years with occasional Vitamin D testing and surveying in order to collect information on recurrence and survival outcomes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 13, 2015
Enrollment StartMar 1, 2016
Primary CompletionJun 1, 2020
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 10.6 years ago

Interventions

cholecalciferoldietary

2,000 IU of Vitamin D3 daily and 50,000 IU Vitamin D3 daily