Vitamin D3 for Aromatase Inhibitor Induced Arthralgias (VITAL)

• ClinicalTrials.gov Identifier: NCT00867217
• Recruitment Status: Completed
• First Posted: March 23, 2009
• Results First Posted: February 9, 2018
• Last Update Posted: February 9, 2018
• Sponsor: Qamar Khan
• Collaborators: Novartis Pharmaceuticals; BTR Group
• Information provided by (Responsible Party): Qamar Khan, University of Kansas Medical Center

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Dietary Supplement: High Dose Vitamin D; Dietary Supplement: Placebo; Dietary Supplement: Standard Dose Vitamin D3; Drug: Letrozole 2.5mg	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official 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).
• Study Start Date: March 2009
• Actual Primary Completion Date: January 2011
• Actual Study Completion Date: January 2011

Arms and Interventions

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: 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.

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Kansas

University of Kansas Medical Center

Westwood, Kansas, United States, 66205

Cancer Centers of Kansas, P.A.

Wichita, Kansas, United States, 67214

Sponsors and Collaborators

Qamar Khan

Novartis Pharmaceuticals

BTR Group

Investigators

• Principal Investigator: Qamar J Khan, MD; University of Kansas Medical Center

More Information

• Responsible Party: Qamar Khan, Associate Professor, University of Kansas Medical Center
• ClinicalTrials.gov Identifier: NCT00867217
• Other Study ID Numbers: 11548
• First Posted: March 23, 2009
• Results First Posted: February 9, 2018
• Last Update Posted: February 9, 2018
• Last Verified: January 2018

Additional relevant MeSH terms:

Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins; Letrozole; Micronutrients; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Antineoplastic Agents; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists