High Dose Vitamin D for Breast

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Levine Cancer Institute, Charlotte, NC
Breast
High Dose Vitamin D - DietarySupplement
Eligibility
18 - 65
Female
Eligible conditions
Select

Study Summary

This study is evaluating whether early intensive vitamin D supplementation is more effective than standard of care vitamin D supplementation in improving bone health.

See full description

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether High Dose Vitamin D will improve 1 primary outcome in patients with Breast. Measurement will happen over the course of 18 month period.

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

Trial Safety

Safety Progress

1 of 3

Side Effects for

High Dose Vitamin D
General disorders
71%
Psychiatric disorders
55%
Injury, poisoning, and procedural complications
53%
Respiratory, thoracic, and mediastinal disorders
44%
Skin and subcutaneous disorders
42%
Gastrointestinal disorders
40%
Infections and infestations
38%
Metabolic and nutrition disorders
33%
Musculoskeletal and connective tissue disorders
31%
Investigations
29%
Cardiac disorders
27%
Surgical and medical procedures
25%
Renal and urinary disorders
24%
Nervous system disorders
18%
Death
16%
Immune system disorders
16%
Blood and lymphatic system disorders
13%
Ear and labyrinth disorders
11%
Reproductive system disorders
11%
Eye disorders
9%
Endocrine disorders
5%
Hepatobiliary disorders
2%
Neoplasms
2%
Social circumstances
2%
This histogram enumerates side effects from a completed 2016 Phase 2 trial (NCT01102374) in the High Dose Vitamin D ARM group. Side effects include: General disorders with 71%, Psychiatric disorders with 55%, Injury, poisoning, and procedural complications with 53%, Respiratory, thoracic, and mediastinal disorders with 44%, Skin and subcutaneous disorders with 42%.

Trial Design

2 Treatment Groups

SOC Vit D
1 of 2
High Vit D
1 of 2
Active Control
Experimental Treatment

This trial requires 128 total participants across 2 different treatment groups

This trial involves 2 different treatments. High Dose Vitamin D is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

High Vit D
DietarySupplement
High Dose Vitamin D
SOC Vit D
DietarySupplement
Standard of Care Vitamin D
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vitamin D
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 18 month period
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 18 month period for reporting.

Closest Location

Levine Cancer Institute - Charlotte, NC

Eligibility Criteria

This trial is for female patients between 18 and 65 years old. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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

Patient Q&A Section

What is breast?

"Breast cancers are cancers that develop in the breast after sex, when breast tissue enlarges, and usually are found in women older than 50. Half of women have mammograms and half of women are diagnosed with breast cancer. Breast cancer is a group of overlapping tumours." - Anonymous Online Contributor

Unverified Answer

Can breast be cured?

"Not if you are overweight at the moment, but to get normal and a normal proportion from your breasts can be really small breasts or a small bust, and a small waist; that would make your breasts look real good, so do this. This is how you can become the best body you have ever been. Then you would have the best breasts in the whole world. You can be the best body, and your breasts can be the best and the most beautiful breasts in the whole, and in the whole world." - Anonymous Online Contributor

Unverified Answer

What are common treatments for breast?

"Cognitive behavioural therapy (CBT), such as cognitive behavioural therapy for insomnia or psychotherapy for insomnia, is often used in conjunction with antidepressants and sleep medication to treat insomnia associated with breast cancer. There is also evidence for the use of CBT for depressive disorders in women with breast cancer. The benefits of CBT may be enhanced by aromatase inhibitor therapy. Cognitive behavioural therapy is also used in conjunction with antiplatelet agents in the treatment of postmenopausal women." - Anonymous Online Contributor

Unverified Answer

What causes breast?

"This investigation of the causes of breast cancer has uncovered a rich array of contributory factors, but, for most cases, the cause cannot be identified." - Anonymous Online Contributor

Unverified Answer

What are the signs of breast?

"Symptoms of breast are common. There are a number of signs and symptoms that an experienced practitioner should be aware of. These include soreness, tenderness and changing size of the breasts." - Anonymous Online Contributor

Unverified Answer

How many people get breast a year in the United States?

"around 10,300,000 US women live in the US with breast disease in the United States. This makes up around 1.3% of women in the US." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of high dose vitamin d?

"High dose vitamin D has shown efficacy in preventing hypocalcemia resulting from hypervitaminosis D in adult patients. Although transient hypocalcemia seems to be common, this study found no evidence of delayed calcification as previously described." - Anonymous Online Contributor

Unverified Answer

Is high dose vitamin d safe for people?

"Low-dose ergocalciferol given daily for 2 years is safe in apparently healthy postmenopausal women. However, long-term studies in the context of other potential adverse effects of vitamin D on morbidity and mortality are needed to support recommendations for its adoption." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets breast?

"The average age women would be first experiencing the physical side effect of breast problems may be between the ages of 45 to 55. The greatest number of complaints from women come from the age group 45–49, and the most common initial complaint of breast complaints is lump in the breast, which is not uncommon. Complaints of breast tenderness are the second of the common physical first signs of breast problems and come from the group 19–45. The average age of onset of breast problems such as breast pain, breast lump, and breast atrophy is 49-59. On the physical side of the breasts, women complain that, among other things, their breast have become smaller, less full, or less firm." - Anonymous Online Contributor

Unverified Answer

Does breast run in families?

"Results from a recent paper highlights a genetic predisposition to breast carcinoma not only in Jewish women but also in Caucasian women who are of a lower socioeconomic status." - Anonymous Online Contributor

Unverified Answer

Does high dose vitamin d improve quality of life for those with breast?

"Results from a recent paper suggests that a high dose of vitamin D supplementation may improve quality of life in this population of breast cancer patients." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving high dose vitamin d?

"Recent findings showed no benefit of high-dose vitamin D (800 micrograms/day plus 2-5 micrograms Ca per day) on mortality, CV or all-cause morbidity, although there was no non-significant difference. More data are needed to clarify the relationship between vitamin D and cancer. Moreover, because of the observational study design we cannot establish causality. The effect of vitamin D on mortality could be secondary and in that case one will not find a significant effect on cause-specific mortality." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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