Trial Outcomes & Findings for Study of Vitamin D for Premenopausal Women at High Risk for Breast Cancer (NCT NCT00976339)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

20 participants

Primary outcome timeframe

1 year

Results posted on

2017-09-29

Participant Flow

Referrals to the Columbia breast oncology clinic for breast cancer chemoprevention will be recruited medical oncologist or via recruitment flyers. Recruitment letters will be sent to high-risk women who participated in the Metropolitan Breast Cancer Family Registry and Women at Risk (WAR) database.

Participant milestones

Participant milestones
Measure	Cholecalciferol 20,000 IU Subjects received Cholecalciferol 20,000 IU weekly for 1 year.	Cholecalciferol 30,000 IU Subjects received Cholecalciferol 30,000 IU weekly for one year
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Vitamin D for Premenopausal Women at High Risk for Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cholecalciferol 20,000 IU n=10 Participants Subjects received Cholecalciferol 20,000 IU weekly, for 1 year	Cholecalciferol 30,000 IU n=10 Participants Subjects received Cholecalciferol 30,000 IU weekly, for 1 year	Total n=20 Participants Total of all reporting groups
Age, Customized > 21 years	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Data for this study (NCT00976339) is combined with the data for another study (NCT00859651); see NCT00859651 for combined results. Investigator is unable to determine the subject data that should be entered for this study alone, since subject data was combined for the purpose of data analysis. Data for this study alone was not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: Data for this study (NCT00976339) is combined with the data for another study (NCT00859651); see NCT00859651 for combined results. Investigator is unable to determine the subject data that should be entered for this study alone, since subject data was combined for the purpose of data analysis. Data for this study alone was not analyzed.

Outcome measures

Outcome data not reported

Adverse Events

Cholecalciferol 20,000 IU

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cholecalciferol 30,000 IU

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Katherine Crew

Columbia University

Phone: 212-305-1732

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place