CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Cholecalciferol +1 moredrug
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/NCT00859651
NCT00859651Phase 2Completed

Effects of High-Dose Vitamin D on Circulating Vitamin D Levels and Breast Density in Postmenopausal Women at High Risk for Breast Cancer Development

Columbia University·interventional·Posted Mar 11, 2009·Updated Sep 27, 2017

In Brief

A Phase 2 clinical trial evaluating Cholecalciferol and Placebo capsule for Breast Cancer. Completed, enrolled 20 participants across 1 site.

Detailed Summary

This is a phase II study which will enroll 20 postmenopausal women who are at high risk for breast cancer development. The goal is to determine whether a one-year intervention of high-dose vitamin D at 2 different doses (20,000 IU weekly or 30,000 IU weekly) will increase circulating blood levels of vitamin D and to obtain preliminary data on the biologic effects of vitamin D for breast cancer prevention.

Study Details

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

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 11, 2009
Enrollment StartJun 1, 2009
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 17.3 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.

Placebo capsuledrug

Matching placebo capsules