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

Not Applicable

Completed

• Conditions: Breast Cancer; Osteoporosis; Breast
• Interventions: Dietary Supplement: High Dose Vitamin D; Dietary Supplement: Standard of Care Vitamin D

• Registration Number: NCT05016310
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-08-17
• Study First Submitted QC: 2021-08-17
• Study First Posted: 2021-08-23
• Study Start: 2021-09-16
• Primary Completion: 2024-02-21
• Study Completion: 2024-08-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 7

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Vit D	High Dose Vitamin D	High Dose Vitamin D
SOC Vit D	Standard of Care Vitamin D	Standard of Care Vitamin D

Primary Outcome Measures

Name	Time	Method
Percent change from baseline in bone mineral density (g/cm^2) from baseline to the Year 1 DEXA scan	15 months (12 plus a +3 month calendar window)	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.

Secondary Outcome Measures

Name	Time	Method
25(OH) D level over time	18 months	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.
PRAI questionnaire results over time	18 months	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.
Skeletal complications over time	18 months	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.
Overall satisfaction with pain control over time	18 months	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.

Trial Locations

Locations (1)

Levine Cancer Institute; 🇺🇸 Charlotte, North Carolina, United States