Trial Outcomes & Findings for Vitamin D in Postmenopausal Women at High Risk for Breast Cancer (NCT NCT00859651)
NCT ID: NCT00859651
Last Updated: 2017-09-27
Results Overview
25(OH)D level at the end of one year intervention
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Baseline to 1 year
Results posted on
2017-09-27
Participant Flow
Data for this study (NCT00859651; n=20 postmenopausal; 8 received 20,000 IU/week and 12 received 30,000 IU/week) is combined with the data for another study (NCT00976339; n=20 premenopausal; 10 received 20,000 IU/week and 10 received 30,000 IU/week). Resulting in a combination of 18 receiving 20,000 IU/week and 22 receiving 30,000 IU/week.
Participant milestones
| Measure |
Cholecalciferol 20,000 IU Group
Postmenopausal women who are at increased risk for breast cancer development receiving vitamin D3, oral cholecalciferol 20,000 IU weekly, for one year.
|
Cholecalciferol 30,000 IU Group
Postmenopausal women who are at increased risk for breast cancer development receiving vitamin D3, oral cholecalciferol 30,000 IU weekly, for one year.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
22
|
|
Overall Study
COMPLETED
|
18
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vitamin D in Postmenopausal Women at High Risk for Breast Cancer
Baseline characteristics by cohort
| Measure |
Cholecalciferol 20,000 IU Group
n=18 Participants
Postmenopausal women who are at increased risk for breast cancer development receiving vitamin D3, oral cholecalciferol 20,000 IU weekly, for one year.
|
Cholecalciferol 30,000 IU Group
n=22 Participants
Postmenopausal women who are at increased risk for breast cancer development receiving vitamin D3, oral cholecalciferol 30,000 IU weekly, for one year.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.0 years
n=5 Participants
|
50.5 years
n=7 Participants
|
50 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
40 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
|
18 participants
n=5 Participants
|
22 participants
n=7 Participants
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 1 yearPopulation: Data for this study (NCT00859651; n=20) is combined with the data for another study (NCT00976339; n=20).
25(OH)D level at the end of one year intervention
Outcome measures
| Measure |
Cholecalciferol 20,000 IU Group
n=18 Participants
Postmenopausal women who are at increased risk for breast cancer development receiving vitamin D3, oral cholecalciferol 20,000 IU weekly, for one year.
|
Cholecalciferol 30,000 IU Group
n=22 Participants
Postmenopausal women who are at increased risk for breast cancer development receiving vitamin D3, oral cholecalciferol 30,000 IU weekly, for one year.
|
|---|---|---|
|
Change in Serum 25(OH)D
|
25 ng/ml
Standard Deviation 5
|
33 ng/ml
Standard Deviation 9
|
SECONDARY outcome
Timeframe: Baseline to 1 yearPopulation: Data for this study (NCT00859651; n=20) is combined with the data for another study (NCT00976339; n=20).
Assessed by mammography and breast MRI.
Outcome measures
| Measure |
Cholecalciferol 20,000 IU Group
n=18 Participants
Postmenopausal women who are at increased risk for breast cancer development receiving vitamin D3, oral cholecalciferol 20,000 IU weekly, for one year.
|
Cholecalciferol 30,000 IU Group
n=22 Participants
Postmenopausal women who are at increased risk for breast cancer development receiving vitamin D3, oral cholecalciferol 30,000 IU weekly, for one year.
|
|---|---|---|
|
Change in Percent Density
|
3 percentage of breast density
Standard Deviation 1
|
1 percentage of breast density
Standard Deviation 1
|
Adverse Events
Cholecalciferol 20,000 IU
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Cholecalciferol 30,000 IU
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cholecalciferol 20,000 IU
n=18 participants at risk
Postmenopausal women who are at increased risk for breast cancer development receiving vitamin D3, oral cholecalciferol 20,000 IU weekly, for one year.
|
Cholecalciferol 30,000 IU
n=22 participants at risk
Postmenopausal women who are at increased risk for breast cancer development receiving vitamin D3, oral cholecalciferol 30,000 IU weekly, for one year.
|
|---|---|---|
|
Cardiac disorders
Hypertension
|
5.6%
1/18
For the Outcome Measure data analysis, the investigator combined the data for this study (NCT00859651; n=20) with the data for another study (NCT00976339; n=20), since both studies are under the same investigational new drug (IND). Therefore, the total number of participants analyzed is 40.
|
0.00%
0/22
For the Outcome Measure data analysis, the investigator combined the data for this study (NCT00859651; n=20) with the data for another study (NCT00976339; n=20), since both studies are under the same investigational new drug (IND). Therefore, the total number of participants analyzed is 40.
|
|
General disorders
Fatigue
|
5.6%
1/18
For the Outcome Measure data analysis, the investigator combined the data for this study (NCT00859651; n=20) with the data for another study (NCT00976339; n=20), since both studies are under the same investigational new drug (IND). Therefore, the total number of participants analyzed is 40.
|
27.3%
6/22
For the Outcome Measure data analysis, the investigator combined the data for this study (NCT00859651; n=20) with the data for another study (NCT00976339; n=20), since both studies are under the same investigational new drug (IND). Therefore, the total number of participants analyzed is 40.
|
|
Investigations
Weight gain
|
5.6%
1/18
For the Outcome Measure data analysis, the investigator combined the data for this study (NCT00859651; n=20) with the data for another study (NCT00976339; n=20), since both studies are under the same investigational new drug (IND). Therefore, the total number of participants analyzed is 40.
|
0.00%
0/22
For the Outcome Measure data analysis, the investigator combined the data for this study (NCT00859651; n=20) with the data for another study (NCT00976339; n=20), since both studies are under the same investigational new drug (IND). Therefore, the total number of participants analyzed is 40.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
1/18
For the Outcome Measure data analysis, the investigator combined the data for this study (NCT00859651; n=20) with the data for another study (NCT00976339; n=20), since both studies are under the same investigational new drug (IND). Therefore, the total number of participants analyzed is 40.
|
22.7%
5/22
For the Outcome Measure data analysis, the investigator combined the data for this study (NCT00859651; n=20) with the data for another study (NCT00976339; n=20), since both studies are under the same investigational new drug (IND). Therefore, the total number of participants analyzed is 40.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
2/18
For the Outcome Measure data analysis, the investigator combined the data for this study (NCT00859651; n=20) with the data for another study (NCT00976339; n=20), since both studies are under the same investigational new drug (IND). Therefore, the total number of participants analyzed is 40.
|
13.6%
3/22
For the Outcome Measure data analysis, the investigator combined the data for this study (NCT00859651; n=20) with the data for another study (NCT00976339; n=20), since both studies are under the same investigational new drug (IND). Therefore, the total number of participants analyzed is 40.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
33.3%
6/18
For the Outcome Measure data analysis, the investigator combined the data for this study (NCT00859651; n=20) with the data for another study (NCT00976339; n=20), since both studies are under the same investigational new drug (IND). Therefore, the total number of participants analyzed is 40.
|
31.8%
7/22
For the Outcome Measure data analysis, the investigator combined the data for this study (NCT00859651; n=20) with the data for another study (NCT00976339; n=20), since both studies are under the same investigational new drug (IND). Therefore, the total number of participants analyzed is 40.
|
|
Nervous system disorders
Headache
|
5.6%
1/18
For the Outcome Measure data analysis, the investigator combined the data for this study (NCT00859651; n=20) with the data for another study (NCT00976339; n=20), since both studies are under the same investigational new drug (IND). Therefore, the total number of participants analyzed is 40.
|
4.5%
1/22
For the Outcome Measure data analysis, the investigator combined the data for this study (NCT00859651; n=20) with the data for another study (NCT00976339; n=20), since both studies are under the same investigational new drug (IND). Therefore, the total number of participants analyzed is 40.
|
|
Psychiatric disorders
Insomnia
|
5.6%
1/18
For the Outcome Measure data analysis, the investigator combined the data for this study (NCT00859651; n=20) with the data for another study (NCT00976339; n=20), since both studies are under the same investigational new drug (IND). Therefore, the total number of participants analyzed is 40.
|
0.00%
0/22
For the Outcome Measure data analysis, the investigator combined the data for this study (NCT00859651; n=20) with the data for another study (NCT00976339; n=20), since both studies are under the same investigational new drug (IND). Therefore, the total number of participants analyzed is 40.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/18
For the Outcome Measure data analysis, the investigator combined the data for this study (NCT00859651; n=20) with the data for another study (NCT00976339; n=20), since both studies are under the same investigational new drug (IND). Therefore, the total number of participants analyzed is 40.
|
4.5%
1/22
For the Outcome Measure data analysis, the investigator combined the data for this study (NCT00859651; n=20) with the data for another study (NCT00976339; n=20), since both studies are under the same investigational new drug (IND). Therefore, the total number of participants analyzed is 40.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/18
For the Outcome Measure data analysis, the investigator combined the data for this study (NCT00859651; n=20) with the data for another study (NCT00976339; n=20), since both studies are under the same investigational new drug (IND). Therefore, the total number of participants analyzed is 40.
|
9.1%
2/22
For the Outcome Measure data analysis, the investigator combined the data for this study (NCT00859651; n=20) with the data for another study (NCT00976339; n=20), since both studies are under the same investigational new drug (IND). Therefore, the total number of participants analyzed is 40.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/18
For the Outcome Measure data analysis, the investigator combined the data for this study (NCT00859651; n=20) with the data for another study (NCT00976339; n=20), since both studies are under the same investigational new drug (IND). Therefore, the total number of participants analyzed is 40.
|
27.3%
6/22
For the Outcome Measure data analysis, the investigator combined the data for this study (NCT00859651; n=20) with the data for another study (NCT00976339; n=20), since both studies are under the same investigational new drug (IND). Therefore, the total number of participants analyzed is 40.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/18
For the Outcome Measure data analysis, the investigator combined the data for this study (NCT00859651; n=20) with the data for another study (NCT00976339; n=20), since both studies are under the same investigational new drug (IND). Therefore, the total number of participants analyzed is 40.
|
9.1%
2/22
For the Outcome Measure data analysis, the investigator combined the data for this study (NCT00859651; n=20) with the data for another study (NCT00976339; n=20), since both studies are under the same investigational new drug (IND). Therefore, the total number of participants analyzed is 40.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/18
For the Outcome Measure data analysis, the investigator combined the data for this study (NCT00859651; n=20) with the data for another study (NCT00976339; n=20), since both studies are under the same investigational new drug (IND). Therefore, the total number of participants analyzed is 40.
|
18.2%
4/22
For the Outcome Measure data analysis, the investigator combined the data for this study (NCT00859651; n=20) with the data for another study (NCT00976339; n=20), since both studies are under the same investigational new drug (IND). Therefore, the total number of participants analyzed is 40.
|
|
Metabolism and nutrition disorders
Hypercalciuria
|
0.00%
0/18
For the Outcome Measure data analysis, the investigator combined the data for this study (NCT00859651; n=20) with the data for another study (NCT00976339; n=20), since both studies are under the same investigational new drug (IND). Therefore, the total number of participants analyzed is 40.
|
4.5%
1/22
For the Outcome Measure data analysis, the investigator combined the data for this study (NCT00859651; n=20) with the data for another study (NCT00976339; n=20), since both studies are under the same investigational new drug (IND). Therefore, the total number of participants analyzed is 40.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place