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

NCT05016310 | Completed

• 2 other identifiers: LCI-BRE-VITD-00100055909
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast; Breast Cancer; Osteoporosis

Keywords

Bone Density

Outcome Measures

Primary Outcomes (1)

• Percent change from baseline in bone mineral density (g/cm^2) from baseline to the Year 1 DEXA scan

  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.

  15 months (12 plus a +3 month calendar window)

Secondary Outcomes (4)

• 25(OH) D level over time

  18 months

• PRAI questionnaire results over time

  18 months

• Overall satisfaction with pain control over time

  18 months

• Skeletal complications over time

  18 months

Other Outcomes (5)

• Vitamin D administration

  18 months

• Adverse events of special interest

  19 months

• Adverse events of special interest leading to vitamin D dose modifications or discontinuations

  18 months

Study Arms (2)

High Vit D

EXPERIMENTAL

High Dose Vitamin D

Dietary Supplement: High Dose Vitamin D

SOC Vit D

ACTIVE COMPARATOR

Standard of Care Vitamin D

Dietary Supplement: Standard of Care Vitamin D

Interventions

High Dose Vitamin D DIETARY_SUPPLEMENT

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.

High Vit D

Standard of Care Vitamin D DIETARY_SUPPLEMENT

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.

SOC Vit D

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
• Age; 45 years at the time of consent
• Female
• Histological or cytological confirmation of breast cancer clinical or pathologic stages 0-III
• Patient has been recommended to initiate systemic therapy for breast cancer. It is preferable for patient to enroll prior to systemic therapy initiation. However, enrollment will be allowed if systemic therapy has been initiated within 4 weeks prior to enrollment (randomization).
• Note: Patients who undergo only surgery and/or radiotherapy alone would not qualify for the study.
• Systemic therapy for breast cancer is planned
• As determined by the enrolling physician, ability of the subject to understand and comply with study procedures for the entire length of the study
• Previous vitamin D supplementation allowed, as long as patient is agreeable to stop previous dosing at the time of trial enrollment, to comply with trial procedures including a baseline 25(OH)D level, and is otherwise determined to be appropriate for enrollment

You may not qualify if:

• Subjects meeting any of the criteria below may not participate in the study:
• Uncontrolled intercurrent illness/medical condition or psychiatric illness/social situations that would limit compliance with study requirements as determined by the Investigator
• Patients will undergo breast surgery and/or radiotherapy alone without planned neoadjuvant and/or adjuvant anti-cancer drug therapy.
• Baseline 25(OH)D level \<10ng/mL or \>80ng/mL
• Baseline serum corrected calcium level of \>10.3mg/dL
• Bone mineral density less than the expected range for age on baseline DEXA scan (defined as Z-score \</= -2.0)
• Breast cancer with distant metastasis
• History of previous breast cancer
• Postmenopausal, as confirmed by the lack of menses \>/=12 months and/or ovarian function laboratories (estradiol, FSH) consistent with menopause (if any of two values outside of menopausal range and subject had menses within 12 months, subject would be considered perimenopausal or premenopausal and therefore eligible for enrollment)
• Pregnancy or lactation
• History of bone disease, including Paget's bone disease or osteomalacia
• Concurrent rheumatoid or other inflammatory arthritis
• Concurrent or prior treatment with bisphosphonates
• Use of oral corticosteroids within the last 30 days prior to randomization
• Concurrent treatment for thyroid deficiency

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Atrium Health Levine Cancer Institute: collaborator

Study Sites (1)

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Osteoporosis

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Arielle Heeke, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 23, 2021
• Study Start: September 16, 2021
• Primary Completion: February 21, 2024
• Study Completion: August 15, 2024
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)