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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 month period

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 month period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 month period

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 month period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent change from baseline in bone mineral density (g/cm^2)

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

Eye disorders

Endocrine disorders

Hepatobiliary disorders

Neoplasms

Social circumstances

100%

80%

60%

40%

20%

Study treatment Arm

High Dose Vitamin D

Standard Dose Vitamin D

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Arielle HeekeLead Sponsor

Wake Forest University Health SciencesLead Sponsor

1,239 Previous Clinical Trials

1,004,176 Total Patients Enrolled

1 Trials studying Breast

102 Patients Enrolled for Breast

Atrium Health Levine Cancer InstituteOTHER

14 Previous Clinical Trials

1,344 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are minors able to participate in this scientific trial?

"Within the parameters of this trial, only individuals from 18 to 45 years old may be enrolled. For those outside that age range, there are 7 trials for minors and 23 studies available for elderly persons."

Answered by AI

How many individuals are enrolled as participants in this experiment?

"Affirmative. According to clinicaltrials.gov, this healthcare research project is currently in need of applicants. It was posted on September 16th 2021 and last updated July 11th 2022; 128 people must be recruited from one medical site for the trial's completion."

Answered by AI

Could you provide a summary of previous experiments that assessed the effects of high-dose Vitamin D?

"At the moment, 33 medical studies regarding High Dose Vitamin d are in progress with 11 of them being on Phase 3. 88 clinical trial sites across the country have enrolled patients for testing this intervention; notablyDallas, Texas has many active trials."

Answered by AI

Are participants being recruited for this clinical trial currently?

"Reported on the clinicaltrials.gov web page, this medical experiment is actively recruiting participants starting from September 16th 2021 and has been updated as recently as July 11th 2022."

Answered by AI

For what type of population is this research endeavor most suitable?

"This research trial seeks 128 female participants between the ages of 18 and 45 who have been diagnosed with breast cancer and are recommended to begin systemic therapy for treatment. To be eligible, individuals must provide written informed consent as well as HIPAA authorization for release of personal health information (which can also be included in their consents). Additionally, they need to demonstrate an understanding and compliance with study procedures throughout its entirety. Furthermore, previous vitamin d supplementation is allowed so long as patients agree to discontinue it at the time enrollment begins while a baseline 25(OH)D level must also be established."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Arielle Heeke 2021. "A Study of High-Dose Vit D Versus Standard of Care Vit D Supplementation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05016310.

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