Trial Outcomes & Findings for Modulation of Breast Cancer Risk Biomarkers by High Dose Vitamin D (NCT NCT01166763)

NCT ID: NCT01166763

Last Updated: 2016-07-18

Results Overview

Change in the percent of the breast area that is considered to be at higher density on mammogram.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: baseline and 6 months
• Results posted on: 2016-07-18

Participant Flow

Recruitment April 2009 to December 2010. Breast Cancer Prevetnion Center at University of Kansas Medical Center

Participant milestones

Measure	High Dose Vitamin D3 (10,000 IU Weekly) Group/Cohort Label vitamin D3 vitamin D3: oral capsules, 10,000 IU per week for 6 months
Overall Study STARTED	30
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	High Dose Vitamin D3 (10,000 IU Weekly) Group/Cohort Label vitamin D3 vitamin D3: oral capsules, 10,000 IU per week for 6 months
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Modulation of Breast Cancer Risk Biomarkers by High Dose Vitamin D

Baseline characteristics by cohort

Measure	High Dose Vitamin D3 (10,000 IU Weekly) n=30 Participants Group/Cohort Label vitamin D3 vitamin D3: oral capsules, 10,000 IU per week for 6 months
Age, Continuous	41.4 years STANDARD_DEVIATION 4.9 • n=5 Participants
Sex/Gender, Customized Female	30 participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Gail Risk 5-year Probability of Cancer Development	1.6 percent probability STANDARD_DEVIATION 1.2 • n=5 Participants

PRIMARY outcome

Timeframe: baseline and 6 months

Population: All subjects completing trial

Change in the percent of the breast area that is considered to be at higher density on mammogram.

Outcome measures

Measure	High Dose Vitamin D3 (10,000 IU Weekly) n=27 Participants Group/Cohort Label vitamin D3 vitamin D3: oral capsules, 10,000 IU per week for 6 months
Change in Mammographic Breast Density Over Course of Study	-0.5 Change in percent dense breast area Standard Deviation 5.8

SECONDARY outcome

Timeframe: baseline and 6 months

Population: All subjects completing trial.

Change in percent of cells expressing staining for Ki-67 antibody in breast epithelial cell specimens acquird by Random Periareolar Fine Needle Aspiration.

Outcome measures

Measure	High Dose Vitamin D3 (10,000 IU Weekly) n=27 Participants Group/Cohort Label vitamin D3 vitamin D3: oral capsules, 10,000 IU per week for 6 months
Change in Proliferation (as Assessed by Ki-67) Examined in Breast Epithelial Cells.	-0.4 percentage of cells staining positive Interval -4.0 to 4.8

SECONDARY outcome

Timeframe: baseline and 6 months

Population: All subjects completing trial

Assessment of 25(OH)D levels as a measure of circulating vitamin D.

Outcome measures

Measure	High Dose Vitamin D3 (10,000 IU Weekly) n=27 Participants Group/Cohort Label vitamin D3 vitamin D3: oral capsules, 10,000 IU per week for 6 months
OH Vitamin D Levels in Serum	55.4 ng/ml Standard Deviation 13.8

Adverse Events

High Dose Vitamin D3 (10,000 IU Weekly)

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	High Dose Vitamin D3 (10,000 IU Weekly) n=30 participants at risk Group/Cohort Label vitamin D3 vitamin D3: oral capsules, 10,000 IU per week for 6 months
Gastrointestinal disorders Cholecystitis	3.3% 1/30 • Number of events 1 • 6 months duration of study agent administration
Nervous system disorders Flank pain	3.3% 1/30 • Number of events 1 • 6 months duration of study agent administration
Gastrointestinal disorders Increase in diarrhea	3.3% 1/30 • Number of events 1 • 6 months duration of study agent administration

Other adverse events

Measure	High Dose Vitamin D3 (10,000 IU Weekly) n=30 participants at risk Group/Cohort Label vitamin D3 vitamin D3: oral capsules, 10,000 IU per week for 6 months
Nervous system disorders Headache	6.7% 2/30 • Number of events 30 • 6 months duration of study agent administration
Gastrointestinal disorders Abdominal cramps	3.3% 1/30 • Number of events 2 • 6 months duration of study agent administration

Additional Information

Bruce F. Kimler, Ph.D.

University of Kansas Medical Center

Phone: 913-588-4523

Email: bkimler@kumc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place