Vitamin D3 for Aromatase Inhibitor Induced Arthralgias (VITAL)

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Dietary supplement: High Dose Vitamin D; Dietary supplement: Standard Dose Vitamin D3; Drug: Letrozole 2.5mg; Dietary supplement: Placebo

Detailed Description

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,

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Westwood, Kansas, United States, 66205
      • University of Kansas Medical Center
    • Wichita, Kansas, United States, 67214
      • Cancer Centers of Kansas, P.A.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Dose Vitamin D; High Dose Vitamin D3 capsule (3 x 10,000 IU capsules weekly). All subjects also received standard dose vitamin D3 (600 IU daily) and letrozole (2.5 mg daily).	Dietary supplement: High Dose Vitamin D; High Dose Vitamin D3 (3 capsules of 10,000 IU) weekly for 24 weeks.; 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.
Placebo Comparator: Placebo; Placebo matched for High Dose Vitamin D3 capsules. All subjects also received standard dose vitamin D3 (600 IU daily) and letrozole (2.5 mg daily).	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.; Dietary supplement: Placebo; Placebo comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Worsening of Musculoskeletal Symptoms (MS)	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.	Change from Baseline to 24 Weeks

Collaborators and Investigators

• Sponsor: Qamar Khan
• Collaborators: Novartis Pharmaceuticals; BTR Group
• Investigators: Principal Investigator: Qamar J Khan, MD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: March 20, 2009
• First Submitted That Met QC Criteria: March 20, 2009
• First Posted (Estimate): March 23, 2009

Study Record Updates

• Last Update Posted (Actual): February 9, 2018
• Last Update Submitted That Met QC Criteria: January 11, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Micronutrients; Hormone Antagonists; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Vitamin D; Cholecalciferol; Letrozole; Vitamins; Ergocalciferols
• Other Study ID Numbers: 11548