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

NCT ID: NCT05016310

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-16
• Study Completion Date: 2024-08-15

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.

Conditions

Breast; Breast Cancer; Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High Vit D

High Dose Vitamin D

Group Type: EXPERIMENTAL

High Dose Vitamin D

Intervention Type: 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.

SOC Vit D

Standard of Care Vitamin D

Group Type: ACTIVE_COMPARATOR

Standard of Care Vitamin D

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Age; 45 years at the time of consent

3. Female

4. Histological or cytological confirmation of breast cancer clinical or pathologic stages 0-III

5. 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.

6. Systemic therapy for breast cancer is planned

7. As determined by the enrolling physician, ability of the subject to understand and comply with study procedures for the entire length of the study

8. 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

Exclusion Criteria

Subjects meeting any of the criteria below may not participate in the study:

1. Uncontrolled intercurrent illness/medical condition or psychiatric illness/social situations that would limit compliance with study requirements as determined by the Investigator

2. Patients will undergo breast surgery and/or radiotherapy alone without planned neoadjuvant and/or adjuvant anti-cancer drug therapy.

3. Baseline 25(OH)D level <10ng/mL or >80ng/mL

4. Baseline serum corrected calcium level of >10.3mg/dL

5. Bone mineral density less than the expected range for age on baseline DEXA scan (defined as Z-score </= -2.0)

6. Breast cancer with distant metastasis

7. History of previous breast cancer

8. 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)

9. Pregnancy or lactation

10. History of bone disease, including Paget's bone disease or osteomalacia

11. Concurrent rheumatoid or other inflammatory arthritis

12. Concurrent or prior treatment with bisphosphonates

13. Use of oral corticosteroids within the last 30 days prior to randomization

14. Concurrent treatment for thyroid deficiency

15. BMI <18.5

16. Currently receiving treatment for tuberculosis, or planning to receive treatment for tuberculosis during breast cancer treatments

17. History of another primary cancer that required systemic treatment within the last 5 years

18. Any of the following kidney diseases at the time of randomization: active chronic kidney disease >/= stage 3, history of kidney stones, sarcoidosis

19. Gastrointestinal disease that would limit the absorption of pill therapy (i.e. celiac disease, gastric bypass surgery)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Atrium Health Levine Cancer Institute

OTHER

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arielle Heeke, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Levine Cancer Institute

Charlotte, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

00055909

Identifier Type: OTHER

Identifier Source: secondary_id

LCI-BRE-VITD-001

Identifier Type: OTHER

Identifier Source: secondary_id

LCI-BRE-VITD-001

Identifier Type: -

Identifier Source: org_study_id