NCT05259527

Vitamin D Supplementation on Reported Rates of Taxane-Induced Neuropathy

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 (advised to take over the counter (OTC) vitamin D). All participants will have blood drawn for serum vitamin D analysis at Weeks 4, 8, 12, and 24 in order to document Vitamin D levels and titrate vitamin D dose (if needed in the treatment arm). Participants in both arms will complete self-report measures of neuropathic pain at baseline, Week 12, and Week 24.

Conditions

• Neuropathic Pain

Interventions

Type	Name	Description
DRUG	Ergocalciferol Capsules	Vitamin D2 50,000IU by mouth once weekly for 8 weeks then once per month thereafter.
DIETARY_SUPPLEMENT	Cholecalciferol Capsules	Vitamin D3 5,000IU by mouth daily

Timeline

• Start date: 2022-12-19
• Primary completion: 2030-03-31
• Completion: 2030-03-31
• First posted: 2022-02-28
• Last updated: 2025-11-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study