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Completed

NCT Number: NCT00867217

Vitamin D3 for Aromatase Inhibitor Induced Arthralgias

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Kansas Medical Center, Westwood, Kansas, United States

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About this study

The primary hypothesis is that high dose vitamin D3 plus standard dose vitamin D3 prevents the worsening of musculoskeletal symptoms when compared to a standard dose vitamin D3 treatment. This protocol will examine the relationship between vitamin D levels (25-hydroxyvitamin D) and various quality of life measures in women being treated with letrozole as standard care for early stage breast cancer. All subjects received letrozole and a standard dose of vitamin D3 (600 IU daily). Randomization was between high dose vitamin D3 (30,000 IU once per week) vs. a blinded, matched placebo,

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Post-menopausal women newly diagnosed with early stage breast cancer, who would be treated with an aromatase inhibitor
  • Serum 25OHD levels < 40 ng/ml

Exclusion criteria

  • Severe or debilitating musculoskeletal pain
  • Known metastatic disease
  • History of renal stones
  • History of hypercalcemia or hyperthyroidism
  • Currently receiving adjuvant or neoadjuvant chemotherapy
  • Currently receiving other investigational agents

Treatment and study plan

High Dose Vitamin D

Dietary Supplement

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

Placebo

Dietary Supplement

Placebo comparator

Standard Dose Vitamin D3

Dietary Supplement

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

Letrozole 2.5mg

Drug

All subjects received letrozole as standard of care.

Primary outcomes

  1. Number of Participants With Worsening of Musculoskeletal Symptoms (MS)

    Time frame: Change from Baseline to 24 Weeks

    Worsening of Musculoskeletal Symptoms (MS) is defined as any one of the following three events: (a) an increase by at least 0.25 in the Health Assessment Questionnaire II (HAQ II, a measure of disability from joint pain) score, (b) an increase in patient reported severity of joint and/or muscle pain, or (c) discontinuation from trial prior to 24 weeks specifically because of problems with musculoskeletal symptoms.

Sponsors and collaborators

Lead sponsor

Qamar Khan

Other

Collaborators

  • BTR Group
  • Novartis Pharmaceuticals

Registry information

Official study title

A Randomized Trial to Evaluate the Benefit of High Dose Vitamin D3 on Aromatase Inhibitor Letrozole-Associated Musculoskeletal Symptoms and Fatigue (The VITAL Trial).

Acronym: VITAL

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Mar 23, 2009
Registry last updated
Feb 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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