Trial Outcomes & Findings for Vitamin D and Breast Cancer Biomarkers in Female Patients (NCT NCT01224678)
NCT ID: NCT01224678
Last Updated: 2024-10-08
Results Overview
To evaluate change in mammographic density using the Boyd method after one year of vitamin D supplementation compared to placebo in premenopausal women. The percent change in breast density will be reported here.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
300 participants
Primary outcome timeframe
12 months
Results posted on
2024-10-08
Participant Flow
Participant milestones
| Measure |
Placebo
Patients receive oral placebo once daily for 12 months.
|
Vitamin D
Patients receive oral vitamin D (2000 IU) once daily for 12 months.
|
|---|---|---|
|
Overall Study
STARTED
|
150
|
150
|
|
Overall Study
COMPLETED
|
150
|
150
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vitamin D and Breast Cancer Biomarkers in Female Patients
Baseline characteristics by cohort
| Measure |
Placebo
n=150 Participants
Patients receive oral placebo once daily for 12 months.
|
Vitamin D
n=150 Participants
Patients receive oral vitamin D (2000 IU) once daily for 12 months.
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.3 years
n=99 Participants
|
42.7 years
n=107 Participants
|
43 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
150 Participants
n=99 Participants
|
150 Participants
n=107 Participants
|
300 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
129 Participants
n=99 Participants
|
124 Participants
n=107 Participants
|
253 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
124 Participants
n=99 Participants
|
114 Participants
n=107 Participants
|
238 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
150 Participants
n=99 Participants
|
150 Participants
n=107 Participants
|
300 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: 86 of the 300 patients were analyzed for the primary endpoint
To evaluate change in mammographic density using the Boyd method after one year of vitamin D supplementation compared to placebo in premenopausal women. The percent change in breast density will be reported here.
Outcome measures
| Measure |
Placebo
n=46 Participants
Patients receive oral placebo once daily for 12 months.
|
Vitamin D
n=40 Participants
Patients receive oral vitamin D (2000 IU) once daily for 12 months.
|
|---|---|---|
|
Percent Change (Between Baseline and Month 12) in Mammographic Density by the Boyd Method Compared Between Arms
|
-3.4 percent change
Standard Deviation 7.1
|
-1.4 percent change
Standard Deviation 11.9
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Vitamin D
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=150 participants at risk
Patients receive oral placebo once daily for 12 months.
|
Vitamin D
n=150 participants at risk
Patients receive oral vitamin D (2000 IU) once daily for 12 months.
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.67%
1/150 • Number of events 1
|
0.00%
0/150
|
|
Gastrointestinal disorders
Abdominal pain
|
0.67%
1/150 • Number of events 1
|
0.00%
0/150
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/150
|
0.67%
1/150 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/150
|
0.67%
1/150 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
0.67%
1/150 • Number of events 9
|
0.67%
1/150 • Number of events 7
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/150
|
0.67%
1/150 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.67%
1/150 • Number of events 20
|
0.67%
1/150 • Number of events 18
|
|
Gastrointestinal disorders
Vomiting
|
0.67%
1/150 • Number of events 7
|
0.67%
1/150 • Number of events 10
|
|
General disorders
Pain
|
0.00%
0/150
|
0.67%
1/150 • Number of events 1
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/150
|
0.67%
1/150 • Number of events 1
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.67%
1/150 • Number of events 2
|
0.00%
0/150
|
|
Investigations
GGT increased
|
0.67%
1/150 • Number of events 1
|
0.00%
0/150
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.67%
1/150 • Number of events 1
|
0.00%
0/150
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.67%
1/150 • Number of events 2
|
0.00%
0/150
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/150
|
0.67%
1/150 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.00%
0/150
|
0.67%
1/150 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/150
|
0.67%
1/150 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/150
|
0.67%
1/150 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.67%
1/150 • Number of events 2
|
0.67%
1/150 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.67%
1/150 • Number of events 50
|
0.67%
1/150 • Number of events 49
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.67%
1/150 • Number of events 1
|
0.00%
0/150
|
|
Pregnancy, puerperium and perinatal conditions
Unintended pregnancy
|
0.00%
0/150
|
0.67%
1/150 • Number of events 2
|
|
Reproductive system and breast disorders
Irregular menstruation
|
0.67%
1/150 • Number of events 1
|
0.67%
1/150 • Number of events 1
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.67%
1/150 • Number of events 1
|
0.00%
0/150
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/150
|
0.67%
1/150 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.67%
1/150 • Number of events 1
|
0.00%
0/150
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.67%
1/150 • Number of events 1
|
0.00%
0/150
|
|
Vascular disorders
Hematoma
|
0.67%
1/150 • Number of events 1
|
0.00%
0/150
|
|
Vascular disorders
Hot flashes
|
0.67%
1/150 • Number of events 1
|
0.00%
0/150
|
|
Vascular disorders
Hypertension
|
0.00%
0/150
|
0.67%
1/150 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60