NCT05016310

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast
• Breast Cancer
• Osteoporosis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	High Dose Vitamin D	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.
DIETARY_SUPPLEMENT	Standard of Care Vitamin D	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.

Timeline

• Start date: 2021-09-16
• Primary completion: 2024-02-21
• Completion: 2024-08-15
• First posted: 2021-08-23
• Last updated: 2025-07-23

Locations

1 site across 1 country: United States