CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 20 enrolled
Drug / intervention
Cholecalciferoldrug
Likely dose
Cholecalciferol 10,000 IUfrom 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/NCT00976339
NCT00976339Phase 1Completed
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Pilot Biomarker Modulation Study of Vitamin D in Premenopausal Women at High Risk for Breast Cancer

Katherine D. Crew·interventional·Posted Sep 14, 2009·Updated Sep 29, 2017

In Brief

A Phase 1 clinical trial evaluating Cholecalciferol for Breast Cancer. Completed, enrolled 20 participants across 1 site.

Detailed Summary

This proposal is for a pilot study of 20 premenopausal women at high risk for breast cancer development who will receive high dose vitamin D3, cholecalciferol 20,000 IU (2 capsules) weekly, or 30,000 IU (3 capsules) weekly, for 1 year. The primary objective of this study is to determine the feasibility of a 1-year intervention of vitamin D in this study population. Secondary objectives include evaluating the biologic effects of vitamin D supplementation on blood based and image-based biomarkers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsPrevent Cancer Foundation

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 14, 2009
Enrollment StartSep 1, 2007
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 16.8 years ago

Interventions

Cholecalciferoldrug

Cholecalciferol is a vitamin D3. Vitamin D is important for the absorption of calcium from the stomach and for the functioning of calcium in the body. Cholecalciferol is used to treat or prevent many conditions caused by a lack of vitamin D. Cholecalciferol will be available in gel capsule form at 10,000 IU (0.25 mg cholecalciferol) each.