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RecruitingPhase 2NCT05259527

Vitamin D Supplementation on Reported Rates of Taxane-Induced Neuropathy

Impact of Vitamin D Supplementation on Reported Rates of Taxane-Induced Neuropathy

Sponsor

Virginia Commonwealth University

Enrollment

120 participants

Start Date

Dec 19, 2022

Study Type

INTERVENTIONAL

Conditions

Neuropathic Pain

Summary

This is a two-arm randomized clinical trial in which 80 participants with Vitamin D deficiency and scheduled to begin taxane-based chemotherapy will be randomized to either: 1) prescribed vitamin D replacement or 2) standard of care.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Diagnosis of stage I-III cancer of any type, OR diagnosis of stage IV cancer being treated with curative intent
  • Receiving or scheduled to begin taxane-based chemotherapy at Virginia Commonwealth University (VCU) Health Massey Comprehensive Cancer Center
  • Vitamin D serum level <20 ng/mL Note: study participants with Vitamin D serum level ≥20 ng/mL may be enrolled in the observational arm.

Exclusion Criteria7

  • Pre-existing diagnosis of neuropathy
  • Currently taking prescription Vitamin D (ergocalciferol)
  • Inability to converse in English
  • Pregnancy
  • Chronic kidney disease (stage IV or greater)
  • Known hyperparathyroidism
  • Hypercalcemia: Calcium levels >10.5 mg/dL Note: study participants with calcium levels <10.5 mg/dL may be enrolled in the observational arm.

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Interventions

DRUGErgocalciferol Capsules

Vitamin D2 50,000IU by mouth once weekly for 8 weeks then once per month thereafter.

DIETARY_SUPPLEMENTCholecalciferol Capsules

Vitamin D3 5,000IU by mouth daily

Locations(1)

Virginia Commonwealth University

Richmond, Virginia, United States

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NCT05259527

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