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Vitamin D Supplement

High-Dose Vitamin D for Breast

N/A
Waitlist Available
Led By Arielle Heeke, MD
Research Sponsored by Arielle Heeke
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Systemic therapy for breast cancer is planned
Female
Must not have
Bone mineral density less than the expected range for age on baseline DEXA scan (defined as Z-score </= -2.0)
Patients will undergo breast surgery and/or radiotherapy alone without planned neoadjuvant and/or adjuvant anti-cancer drug therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 months (12 plus a +3 month calendar window)
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the effects of two different vitamin D supplement regimens on bone health.

Who is the study for?
This trial is for women aged 45+ with breast cancer stages 0-III, who are starting systemic therapy (preferably not yet begun or within 4 weeks prior). Participants must be able to follow the study plan and agree to stop any current vitamin D supplements. Exclusions include severe illnesses, certain bone diseases, recent steroid use, low/high baseline vitamin D levels, extreme BMI values, other cancers treated in the last 5 years.
What is being tested?
The study compares high-dose Vitamin D supplementation against standard doses over an 18-month period to see which is better for bone health in breast cancer patients. It's a randomized trial where participants are assigned one of the two treatments by chance.
What are the potential side effects?
While specific side effects aren't listed here, high doses of Vitamin D can sometimes cause nausea, vomiting, weakness or serious problems like kidney damage if blood calcium levels become too high.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for medication treatment for breast cancer.
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I am female.
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My breast cancer is confirmed and is at an early to mid-stage (0-III).
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I am 45 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My bone density is lower than normal for my age.
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I will have breast surgery or radiotherapy without any drug treatment before or after.
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I do not have a condition that affects how my body absorbs medication taken by mouth.
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I have had breast cancer before.
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I am being treated for tuberculosis during my breast cancer treatment.
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I have taken bisphosphonates for my condition.
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I have rheumatoid or another type of inflammatory arthritis.
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I have a kidney condition, like chronic disease stage 3 or higher, kidney stones, or sarcoidosis.
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I have had another cancer that needed treatment through the bloodstream in the last 5 years.
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I am currently being treated for an underactive thyroid.
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I haven't taken oral steroids in the last 30 days.
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I have a history of bone disease like Paget's or osteomalacia.
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My breast cancer has spread to distant parts of my body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 months (12 plus a +3 month calendar window)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 months (12 plus a +3 month calendar window) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent change from baseline in bone mineral density (g/cm^2) from baseline to the Year 1 DEXA scan
Secondary study objectives
25(OH) D level over time
Overall satisfaction with pain control over time
PRAI questionnaire results over time
+1 more
Other study objectives
Adverse events of special interest
Adverse events of special interest leading to vitamin D dose modifications or discontinuations
Serious adverse events
+2 more

Side effects data

From 2016 Phase 2 trial • 107 Patients • NCT01102374
71%
General disorders
55%
Psychiatric disorders
53%
Injury, poisoning, and procedural complications
44%
Respiratory, thoracic, and mediastinal disorders
42%
Skin and subcutaneous disorders
40%
Gastrointestinal disorders
38%
Infections and infestations
33%
Metabolic and nutrition disorders
31%
Musculoskeletal and connective tissue disorders
29%
Investigations
27%
Cardiac disorders
25%
Surgical and medical procedures
24%
Renal and urinary disorders
18%
Nervous system disorders
16%
Death
16%
Immune system disorders
13%
Blood and lymphatic system disorders
11%
Reproductive system disorders
11%
Ear and labyrinth disorders
9%
Eye disorders
5%
Endocrine disorders
2%
Hepatobiliary disorders
2%
Neoplasms
2%
Social circumstances
100%
80%
60%
40%
20%
0%
Study treatment Arm
High Dose Vitamin D
Standard Dose Vitamin D

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: High Vit DExperimental Treatment1 Intervention
High Dose Vitamin D
Group II: SOC Vit DActive Control1 Intervention
Standard of Care Vitamin D
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
High Dose Vitamin D
2020
Completed Phase 2
~350

Find a Location

Who is running the clinical trial?

Arielle HeekeLead Sponsor
Wake Forest University Health SciencesLead Sponsor
1,394 Previous Clinical Trials
2,460,029 Total Patients Enrolled
1 Trials studying Breast
102 Patients Enrolled for Breast
Atrium Health Levine Cancer InstituteOTHER
26 Previous Clinical Trials
3,656 Total Patients Enrolled
1 Trials studying Breast
102 Patients Enrolled for Breast

Media Library

High Dose Vitamin D (Vitamin D Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05016310 — N/A
Breast Research Study Groups: High Vit D, SOC Vit D
Breast Clinical Trial 2023: High Dose Vitamin D Highlights & Side Effects. Trial Name: NCT05016310 — N/A
High Dose Vitamin D (Vitamin D Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05016310 — N/A
~2 spots leftby Nov 2025
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