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Changes in Biomarkers Using Prostaglandin Inhibitors

NCT01769625 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2017-08-09

No results posted yet for this study

Summary

This is a biomarker study with the goal of measuring changes in proteins and gene methylation. This study is not intended for use in diagnosing, mitigating, treating, curing, or preventing disease.

The purpose of this study is to determine if Vitamin D (cholecalciferol) alone and in combination with celecoxib (Celebrex, a non-steroidal anti-inflammatory drug, or NSAID), act together to decrease breast cancer risk by their effect on certain biological indicators (biomarkers) of breast cancer risk (called PGE2, COX-2, and 15-PGDH) and cell changes in the breast.

Conditions

  • Biomarker Change Linked to Breast Cancer

Interventions

DRUG

placebo/celecoxib 400 mg and cholecalciferol 400 IU/cholecalciferol 2,000 IU

Take 1 capsule from each bottle (1 bottle containing either placebo/celecoxib and 1 bottle containing either cholecaliferol 400 IU/cholecaliferol 2,000 IU) for 30 days

Sponsors & Collaborators

  • Susan G. Komen Breast Cancer Foundation

    collaborator OTHER

  • Hartford Hospital

    lead OTHER

Principal Investigators

  • Edward R. Sauter, MD, PhD, M.H.A · University of North Dakota

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01769625 on ClinicalTrials.gov