BreastNCT05016310
A Study of High-Dose Vit D Versus Standard of Care Vit D Supplementation
A study testing High Dose Vitamin D in people with Breast and Breast Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Breast, Breast Cancer, Osteoporosis
- What is being tested?
- High Dose Vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2021to 15 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Subject must meet all of the following applicable inclusion criteria to participate in this study:
- 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).
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- 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
Who cannot join
- 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)
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- 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
- BMI <18.5
- Currently receiving treatment for tuberculosis, or planning to receive treatment for tuberculosis during breast cancer treatments
- History of another primary cancer that required systemic treatment within the last 5 years
- Any of the following kidney diseases at the time of randomization: active chronic kidney disease >/= stage 3, history of kidney stones, sarcoidosis
- Gastrointestinal disease that would limit the absorption of pill therapy (i.e. celiac disease, gastric bypass surgery)
Trial locations and contacts
1 site in 1 country.
United States1 site
Levine Cancer Institute
Charlotte, North Carolina, 28204
About this study
Official title: 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
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.
Read the 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
- Being tested
- High Dose Vitamin D, Standard of Care Vitamin D
- Keywords
- Bone Density
- Medical subject headings
- Breast Neoplasms, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Dose Vitamin DDietary 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.
Standard of Care Vitamin DDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| High Vit D | Experimental | High Dose Vitamin D Receives: Dietary Supplement: High Dose Vitamin D |
| SOC Vit D | Active comparator | Standard of Care Vitamin D Receives: Dietary Supplement: Standard of Care Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 months (12 plus a +3 month calendar window)
Secondary outcomes (4)
25(OH) D level over time
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.
Measured: 18 months
PRAI questionnaire results over time
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.
Measured: 18 months
Overall satisfaction with pain control over time
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.
Measured: 18 months
Skeletal complications over time
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start16 Sep 2021
- Primary completion21 Feb 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Atrium Health Levine Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Arielle Heeke, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05016310
- Sponsor's protocol ID
- LCI-BRE-VITD-001
- Other IDs
- 00055909, LCI-BRE-VITD-001
- Status last verified
- Jul 2025
- First submitted
- 17 Aug 2021
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05016310
- Acronym / sponsor ID
- LCI-BRE-VITD-001
- Conditions
- Breast, Breast Cancer, Osteoporosis
- Keywords
- Bone Density
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Atrium Health Levine Cancer Institute
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- 21 Feb 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 23 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Vit D | Experimental | Dietary Supplement: High Dose Vitamin DHigh Dose Vitamin D |
| SOC Vit D | Active comparator | Dietary Supplement: Standard of Care Vitamin DStandard of Care Vitamin D |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Subject must meet all of the following applicable inclusion criteria to participate in this study:
- 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
Key exclusion criteria (20 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Dose Vitamin DHigh 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 | High Vit D |
| Standard of Care Vitamin DStandard 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. | Dietary supplement | SOC Vit D |
Primary outcome
Percent change from baseline in bone mineral density (g/cm^2) from baseline to the Year 1 DEXA scan
Time frame: 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.
4 secondary outcomes
25(OH) D level over time
Time frame: 18 months
PRAI questionnaire results over time
Time frame: 18 months
Overall satisfaction with pain control over time
Time frame: 18 months
Skeletal complications over time
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arielle Heeke, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Dose Vitamin D in people with Breast and Breast Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change from baseline in bone mineral density (g/cm^2) from baseline to the Year 1 DEXA scan (time frame: 15 months (12 plus a +3 month calendar window)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.