High Dose Vit D Musculoskeletal Symptoms & Bone Density in Anastrozole-Treated Breast Cancer With Marginal Vit D Status

Early Phase 1

Completed

• Conditions: Breast Neoplasms
• Interventions: Dietary Supplement: Calcium carbonate; Other: Placebo; Drug: Vitamin D

• Registration Number: NCT00263185
• Lead Sponsor: Washington University School of Medicine

Brief Summary

The purpose of this study is to determine whether Vitamin D supplementation reduces the symptoms of muscle stiffness and joint tenderness that some patients may develop after starting therapy with Anastrozole for breast cancer.

Detailed Description

This is a pilot, double-blind, randomized, placebo-controlled study with the following aims:

* To compare the effects of high dose vitamin D versus standard dose vitamin D on musculoskeletal pain in breast cancer patients receiving anastrozole when vitamin D levels are in the insufficient but not deficient range (10 to 29 ng/ml).
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Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-12-06
• Study First Submitted QC: 2005-12-06
• Study First Posted: 2005-12-07
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-18
• Last Update Posted: 2014-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 63

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Observational Group	Calcium carbonate	Patients with a baseline Vitamin D level below 10 ng/ml. * Calcium carbonate 1000 mg/day * Vitamin D 400 units daily.
Active Treatment Group	Calcium carbonate	Patients with baseline 25OH vitamin D level of 10-19 ng/ml. * Calcium carbonate 1000 mg/day * Vitamin D 400 units daily. * Vitamin 50,000 IU/wk x 16 weeks and then once a month for a total of 6 months. Patients with baseline 25OH vitamin D level of 20-29 ng/ml. * Calcium carbonate 1000 mg/day * Vitamin D 400 units daily. * Vitamin 50,000 IU/wk x 8 weeks and then once a month for a total of 6 months.
Control Group	Calcium carbonate	Patients with baseline 25OH vitamin D level of 10-19 ng/ml. * Calcium carbonate 1000 mg/day * Vitamin D 400 units daily. * Placebo once per week x 16 weeks and then once a month for a total of 6 months. Patients with baseline 25OH vitamin D level of 20-29 ng/ml. * Calcium carbonate 1000 mg/day * Vitamin D 400 units daily. * Placebo once per week x 8 weeks and then once a month for a total of 6 months.
Control Group	Placebo	Patients with baseline 25OH vitamin D level of 10-19 ng/ml. * Calcium carbonate 1000 mg/day * Vitamin D 400 units daily. * Placebo once per week x 16 weeks and then once a month for a total of 6 months. Patients with baseline 25OH vitamin D level of 20-29 ng/ml. * Calcium carbonate 1000 mg/day * Vitamin D 400 units daily. * Placebo once per week x 8 weeks and then once a month for a total of 6 months.
Active Treatment Group	Vitamin D	Patients with baseline 25OH vitamin D level of 10-19 ng/ml. * Calcium carbonate 1000 mg/day * Vitamin D 400 units daily. * Vitamin 50,000 IU/wk x 16 weeks and then once a month for a total of 6 months. Patients with baseline 25OH vitamin D level of 20-29 ng/ml. * Calcium carbonate 1000 mg/day * Vitamin D 400 units daily. * Vitamin 50,000 IU/wk x 8 weeks and then once a month for a total of 6 months.
Control Group	Vitamin D	Patients with baseline 25OH vitamin D level of 10-19 ng/ml. * Calcium carbonate 1000 mg/day * Vitamin D 400 units daily. * Placebo once per week x 16 weeks and then once a month for a total of 6 months. Patients with baseline 25OH vitamin D level of 20-29 ng/ml. * Calcium carbonate 1000 mg/day * Vitamin D 400 units daily. * Placebo once per week x 8 weeks and then once a month for a total of 6 months.
Observational Group	Vitamin D	Patients with a baseline Vitamin D level below 10 ng/ml. * Calcium carbonate 1000 mg/day * Vitamin D 400 units daily.

Primary Outcome Measures

Name	Time	Method
To compare the effects of high dose vitamin D versus standard dose vitamin D on musculoskeletal pain in breast cancer patients receiving anastrozole when vitamin D levels are in the insufficient but not deficient range (10 to 29 ng/ml).	6 months for randomized phase, 12 months for open-label phase

Secondary Outcome Measures

Name	Time	Method
To evaluate the prevalence of vitamin D insufficiency/deficiency in post-menopausal women with a history of breast cancer who are treated with anastrozole and have musculoskeletal symptoms versus those who are asymptomatic.	6 months for randomized phase, 12 months for open-label phase
To establish correlations between levels of vitamin D, the levels of PTH, the degree of bone loss and the severity of musculoskeletal symptoms.	6 months
To evaluate the effect of standard dose versus high dose Vitamin D replacement on bone density in post-menopausal women with a history of breast cancer who are treated with anastrozole and have musculoskeletal symptoms.	6 months

Trial Locations

Locations (1)

Washington University; 🇺🇸 St. Louis, Missouri, United States