CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units)drug
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/NCT01074216
NCT01074216Phase 2Completed

Vitamin D Levels in Stage IV Colorectal Cancer Patients: A Phase II Study

Memorial Sloan Kettering Cancer Center·interventional·Posted Feb 24, 2010·Updated Feb 3, 2016

In Brief

A Phase 2 clinical trial evaluating vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units) for Colorectal Cancer. Completed, enrolled 45 participants across 5 sites.

Detailed Summary

The purpose of this study is to find out what effects, good and/or bad, vitamin D blood levels has on stage IV colorectal cancer. Tbe doctors want to see if it is possible to increase low vitamin D levels into normal range using vitamin D supplements taken by mouth. Low vitamin D levels have been associated with worse outcomes in persons who have cancer. Low vitamin D may also cause people to have symptoms such as pain and fatigue. We want to see if increasing low vitamin D levels will help improve cancer outcomes. Vitamin D is routinely repleted in all subjects known to be vitamin D deficient. Therefore, the treatment given would be considered standard of care.

Study Details

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

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 24, 2010
Enrollment StartFeb 1, 2010
Primary CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 16.4 years ago

Interventions

vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units)drug

Patients will be given vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units) three times per week until the target vitamin D level of 40 ng/ml is achieved, and vitamin D3 maintenance initiated at 2,000 International Units daily thereafter.