Trial Outcomes & Findings for Vitamin D Supplementation in Women With DCIS and/or LCIS (NCT NCT02936999)
NCT ID: NCT02936999
Last Updated: 2020-12-16
Results Overview
The proliferation index measured by Ki67 will be described for both baseline (pre) and surgical (post) vitamin D supplementation. A paired t-test or the non-parametric Wilcoxon signed-rank test will be used when appropriate to compare patients' outcome between baseline and after-treatment.
TERMINATED
EARLY_PHASE1
8 participants
28 days +/- 3 days from Day 1 of treatment
2020-12-16
Participant Flow
Participant milestones
| Measure |
Treatment Group
Patients will receive 100,000 IU PO loading dose at Day 1. The loading dose must be administered to the patient at the investigator's site.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vitamin D Supplementation in Women With DCIS and/or LCIS
Baseline characteristics by cohort
| Measure |
Treatment Group
n=8 Participants
Patients will receive 100,000IU PO loading dose at Day 1. The loading dose must be administered to the patient at the investigator's site.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 days +/- 3 days from Day 1 of treatmentPopulation: The study was terminated due to low enrollment and lack of funding; therefore no data were collected.
The proliferation index measured by Ki67 will be described for both baseline (pre) and surgical (post) vitamin D supplementation. A paired t-test or the non-parametric Wilcoxon signed-rank test will be used when appropriate to compare patients' outcome between baseline and after-treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 days +/- 3 days from Day 1 of treatmentPopulation: The study was terminated due to low enrollment and lack of funding therefore no data were collected.
Descriptive statistics (N, mean, median, Min, Max, STD for continuous variables, and N, proportion for categorical variables) will be used to summarize patients' demographics as well as lab results. . A paired t-test or the non-parametric Wilcoxon signed-rank test will be used when appropriate to compare patients' outcome between baseline and after-treatment. A p-value of \<0.05 will be considered statistically significant.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 days +/- 3 days from Day 1 of treatmentPopulation: The study was terminated due to low enrollment and lack of funding; therefore no data were collected.
Descriptive statistics (N, mean, median, Min, Max, STD for continuous variables, and N, proportion for categorical variables) will be used to summarize patients' demographics as well as lab results. . A paired t-test or the non-parametric Wilcoxon signed-rank test will be used when appropriate to compare patients' outcome between baseline and after-treatment. A p-value of \<0.05 will be considered statistically significant.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 days +/- 3 days from Day 1 of treatmentPopulation: The study was terminated due to low enrollment and lack of funding; therefore no data were collected.
Descriptive statistics (N, mean, median, Min, Max, STD for continuous variables, and N, proportion for categorical variables) will be used to summarize patients' demographics as well as lab results. A paired t-test or the non-parametric Wilcoxon signed-rank test will be used when appropriate to compare patients' outcome between baseline and after-treatment. A p-value of \<0.05 will be considered statistically significant.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 days +/- 3 days from Day 1 of treatmentPopulation: The study was terminated due to low enrollment and lack of funding; therefore no data were collected.
Descriptive statistics (N, mean, median, Min, Max, STD for continuous variables, and N, proportion for categorical variables) will be used to summarize patients' demographics as well as lab results. A paired t-test or the non-parametric Wilcoxon signed-rank test will be used when appropriate to compare patients' outcome between baseline and after-treatment. A p-value of \<0.05 will be considered statistically significant.
Outcome measures
Outcome data not reported
Adverse Events
Treatment Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Regulatory Research Coordinator
Inova Health Services
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place