Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Musculoskeletal Diseases

Fatigue

Breast Neoplasms

Arthralgia

Micronutrients

All Drugs and Chemicals

Antineoplastic Agents

Bone Density Conservation Agents

Vitamins

Letrozole

Vitamin D

Cholecalciferol

Aromatase Inhibitors

Ergocalciferols

Trace Elements

Hormones

Calcium

Calcium, Dietary

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Vitamin D3

Calciferol

Ergocalciferol

Vitamin D2

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).

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).

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

High Dose Vitamin D

Placebo

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

Standard Dose Vitamin D3

All subjects received letrozole as standard of care.

Letrozole 2.5mg

Qamar J Khan, MD

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.

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,

Vitamin D3 for Aromatase Inhibitor Induced Arthralgias

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

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.

Novartis Pharmaceuticals

BTR Group

Qamar Khan

Associate Professor

Adverse events were collected either at routine clinical visits or by patient report during periodic phone calls.

Placebo (3 capsules of matching placebo) along with standard of care medication (Standard Dose Vitamin D3; 600 IU of vitamin D3 daily) given weekly for 24 weeks

High Dose Vitamin D3 (3 capsules of 10,000 IU) capsules along with standard of care medication standard of care medication (Standard Dose Vitamin D3; 600 IU of vitamin D3 daily) given weekly

Placebo (3 capsules of matching placebo weekly) along with standard of care medication (Standard Dose Vitamin D3, 600 IU of vitamin D3 daily; letrozole, 2.5 mg daily) for 24 weeks.

High Dose Vitamin D3 (3 capsules of 10,000 IU weekly) along with standard of care medication (Standard Dose Vitamin D3, 600 IU of vitamin D3 daily; letrozole, 2.5 mg daily) for 24 weeks.

Total

Age, Customized

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Bruce Kimler

HAQ II increase by 0.25

Subjective Pain increase

Discontinuation due to AEs

Any of the three measures

High Dose Vitamin D3 (3 capsules of 10,000 IU) capsules along with standard of care medication standard of care medication (Standard Dose Vitamin D3; 600 IU of vitamin D3 daily) given weekly for 24 weeks

Subjects available for analysis included those that had completed the entire study; plus three subjects that had dropped out early specifically because of side effects related to musculoskeletal symptoms (one of the endpoints).

Number of Participants With Worsening of Musculoskeletal Symptoms (MS)

Placebo (3 capsules of matching placebo given weekly) along with standard of care medication (Standard Dose Vitamin D3, 600 IU of vitamin D3 daily; letrozole, 2.5 mg daily) for 24 weeks.

High Dose Vitamin D3 (3 capsules of 10,000 IU given weekly) along with standard of care medication (Standard Dose Vitamin D3, 600 IU of vitamin D3 daily; letrozole, 2.5 mg daily) for 24 weeks.

Overall Study

Nutritional and Metabolic Diseases

Osteoporosis

Breast Diseases

Skin Diseases

Bone Diseases

Bone Diseases, Metabolic

Metabolic Diseases

High dose vitamin D: Subjects will receive 50,000 IU vitamin D2 weekly x 16 weeks followed by 4,000 IU of vitamin D3 daily with a goal 25(OH)D level of ≥45 but ≤80 ng/mL.

Standard of Care Vitamin D: Vitamin D will be supplemented to 25(OH)D levels, with a goal 25(OH)D level of \>30 ng/mL according to Endocrine Society Practice Guidelines.

Standard of Care Vitamin D

Arielle Heeke, MD

This is a randomized study evaluating the effects of early intensive vitamin D supplementation compared to standard of care vitamin D supplementation on bone health over an 18 month period.

This is a randomized, open-label study designed to evaluate the effect of high dose vitamin D versus standard of care vitamin D supplementation on bone health and arthralgias. The randomization will be stratified by hormone receptor status (positive versus negative). The primary objective is to compare the effect of high dose vitamin D to the current standard vitamin D treatment administration algorithm on bone health, as measured by percent change from baseline in bone mineral density (g/cm2), in young women with non-metastatic breast cancer who receive systemic therapy.

A Study of High-Dose Vit D Versus Standard of Care Vit D Supplementation

A Randomized, Open-label Study of High-Dose Vitamin D Versus Standard of Care Vitamin D Supplementation to Evaluate the Impact on Bone Health in Young Women With Early Stage Breast Cancer

Descriptively summarize vitamin D administration for the high dose vitamin D arm and for the current standard vitamin D treatment administration algorithm in young women with non-metastatic breast cancer who receive systemic therapy.

Compare effect of high dose vitamin D to the current standard vitamin D treatment administration algorithm on adverse events of special interest (vitamin D related headaches, irritability, spasticity, nausea, vomiting, and hypercalcemia) in young women with non-metastatic breast cancer who receive systemic therapy.

Compare effect of high dose vitamin D to the current standard vitamin D treatment administration algorithm on adverse events of special interest (vitamin D related headaches, irritability, spasticity, nausea, vomiting, and hypercalcemia) that results in vitamin D dose modifications or discontinuations in young women with non-metastatic breast cancer who receive systemic therapy.

Compare effect of high dose vitamin D to the current standard vitamin D treatment administration algorithm on serious adverse events in young women with non-metastatic breast cancer who receive systemic therapy.

Compare effect of high dose vitamin D to the current standard vitamin D treatment administration algorithm on treatment discontinuation due to vitamin D intake non-compliance.

Compare effect of high dose vitamin D to the current standard vitamin D treatment administration algorithm on bone health, as measured by percent change from baseline in bone mineral density (g/cm2) to the Year 1 planned DEXA scan, in young women with non-metastatic breast cancer who receive systemic therapy.

Compare effect of high dose vitamin D to the current standard vitamin D treatment administration algorithm 25(OH) D levels in young women with non-metastatic breast cancer who receive systemic therapy.

Compare effect of high dose vitamin D to the current standard vitamin D treatment administration algorithm on PRAI questionnaire results in young women with non-metastatic breast cancer who receive systemic therapy.

Compare effect of high dose vitamin D to the current standard vitamin D treatment administration algorithm on overall satisfaction with pain control in young women with non-metastatic breast cancer who receive systemic therapy.

Compare effect of high dose vitamin D to the current standard vitamin D treatment administration algorithm on skeletal complications in young women with non-metastatic breast cancer who receive systemic therapy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Vitamin D3 for Aromatase Inhibitor Induced Arthralgias	NCT00867217	Breast Cancer	High Dose Vitam... Placebo Standard Dose V... Letrozole 2.5mg	18 Years -	University of Kansas Medical Center
A Study of High-Dose Vit D Versus Standard of Care Vit D Supplementation	NCT05016310	Breast Breast Cancer Osteoporosis	High Dose Vitam... Standard of Car...	18 Years - 45 Years	Wake Forest University Health Sciences

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