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Vitamin D3 for Aromatase Inhibitor Induced Arthralgias

NCT00867217 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2018-02-09

Study results available
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Summary

The primary purpose is to determine if high dose vitamin D3 reduces the incidence of musculoskeletal symptoms associated with the aromatase inhibitor letrozole in women with early stage breast cancer and low serum vitamin D levels.

Conditions

Interventions

DIETARY_SUPPLEMENT

High Dose Vitamin D

High Dose Vitamin D3 (3 capsules of 10,000 IU) weekly for 24 weeks.

DIETARY_SUPPLEMENT

Placebo

Placebo comparator

DIETARY_SUPPLEMENT

Standard Dose Vitamin D3

Standard Dose Vitamin D3 (600 IU of vitamin D3 daily)

DRUG

Letrozole 2.5mg

All subjects received letrozole as standard of care.

Sponsors & Collaborators

Principal Investigators

  • Qamar J Khan, MD · University of Kansas Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00867217 on ClinicalTrials.gov