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Vitamin D and Breast Cancer Biomarkers in Female Patients

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ClinicalTrials.gov Identifier: NCT01224678
Recruitment Status : Completed
First Posted : October 20, 2010
Results First Posted : June 25, 2018
Last Update Posted : June 25, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Breast Cancer
Interventions Dietary Supplement: vitamin D
Other: placebo
Enrollment 300
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Vitamin D
Hide Arm/Group Description Patients receive oral placebo once daily for 12 months. Patients receive oral vitamin D (2000 IU) once daily for 12 months.
Period Title: Overall Study
Started 150 150
Completed 150 150
Not Completed 0 0
Arm/Group Title Placebo Vitamin D Total
Hide Arm/Group Description Patients receive oral placebo once daily for 12 months. Patients receive oral vitamin D (2000 IU) once daily for 12 months. Total of all reporting groups
Overall Number of Baseline Participants 150 150 300
Hide Baseline Analysis Population Description
All patients were used for baseline analysis
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 150 participants 150 participants 300 participants
44.3
(24.8 to 55.1)
42.7
(22.7 to 59.4)
43
(22.7 to 59.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants 150 participants 300 participants
Female
150
 100.0%
150
 100.0%
300
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants 150 participants 300 participants
Hispanic or Latino
19
  12.7%
23
  15.3%
42
  14.0%
Not Hispanic or Latino
129
  86.0%
124
  82.7%
253
  84.3%
Unknown or Not Reported
2
   1.3%
3
   2.0%
5
   1.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants 150 participants 300 participants
American Indian or Alaska Native
0
   0.0%
1
   0.7%
1
   0.3%
Asian
9
   6.0%
5
   3.3%
14
   4.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
2
   1.3%
2
   0.7%
Black or African American
14
   9.3%
21
  14.0%
35
  11.7%
White
124
  82.7%
114
  76.0%
238
  79.3%
More than one race
1
   0.7%
4
   2.7%
5
   1.7%
Unknown or Not Reported
2
   1.3%
3
   2.0%
5
   1.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 150 participants 150 participants 300 participants
150
 100.0%
150
 100.0%
300
 100.0%
1.Primary Outcome
Title Percent Change (Between Baseline and Month 12) in Mammographic Density by the Boyd Method Compared Between Arms
Hide Description 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.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
86 of the 300 patients were analyzed for the primary endpoint
Arm/Group Title Placebo Vitamin D
Hide Arm/Group Description:
Patients receive oral placebo once daily for 12 months.
Patients receive oral vitamin D (2000 IU) once daily for 12 months.
Overall Number of Participants Analyzed 46 40
Mean (Standard Deviation)
Unit of Measure: percent change
-3.4  (7.1) -1.4  (11.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Vitamin D
Hide Arm/Group Description Patients receive oral placebo once daily for 12 months. Patients receive oral vitamin D (2000 IU) once daily for 12 months.
All-Cause Mortality
Placebo Vitamin D
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Vitamin D
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/150 (0.00%)      0/150 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Vitamin D
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/150 (0.67%)      1/150 (0.67%)    
Ear and labyrinth disorders     
Vertigo  1  1/150 (0.67%)  1 0/150 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  1/150 (0.67%)  1 0/150 (0.00%)  0
Colitis  1  0/150 (0.00%)  0 1/150 (0.67%)  1
Constipation  1  0/150 (0.00%)  0 1/150 (0.67%)  1
Diarrhea  1  1/150 (0.67%)  9 1/150 (0.67%)  7
Gastroesophageal reflux disease  1  0/150 (0.00%)  0 1/150 (0.67%)  1
Nausea  1  1/150 (0.67%)  20 1/150 (0.67%)  18
Vomiting  1  1/150 (0.67%)  7 1/150 (0.67%)  10
General disorders     
Pain  1  0/150 (0.00%)  0 1/150 (0.67%)  1
Infections and infestations     
Appendicitis perforated  1  0/150 (0.00%)  0 1/150 (0.67%)  1
Infections and infestations - Other, specify  1  1/150 (0.67%)  2 0/150 (0.00%)  0
Investigations     
GGT increased  1  1/150 (0.67%)  1 0/150 (0.00%)  0
Metabolism and nutrition disorders     
Hypercalcemia  1  1/150 (0.67%)  1 0/150 (0.00%)  0
Hyperglycemia  1  1/150 (0.67%)  2 0/150 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back pain  1  0/150 (0.00%)  0 1/150 (0.67%)  6
Musculoskeletal and connective tissue disorder - Other, specify  1  0/150 (0.00%)  0 1/150 (0.67%)  1
Neck pain  1  0/150 (0.00%)  0 1/150 (0.67%)  1
Pain in extremity  1  0/150 (0.00%)  0 1/150 (0.67%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1  1/150 (0.67%)  2 1/150 (0.67%)  1
Nervous system disorders     
Headache  1  1/150 (0.67%)  50 1/150 (0.67%)  49
Intracranial hemorrhage  1  1/150 (0.67%)  1 0/150 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Unintended pregnancy  1  0/150 (0.00%)  0 1/150 (0.67%)  2
Reproductive system and breast disorders     
Irregular menstruation  1  1/150 (0.67%)  1 1/150 (0.67%)  1
Menorrhagia  1  1/150 (0.67%)  1 0/150 (0.00%)  0
Pelvic pain  1  0/150 (0.00%)  0 1/150 (0.67%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  1/150 (0.67%)  1 0/150 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash acneiform  1  1/150 (0.67%)  1 0/150 (0.00%)  0
Vascular disorders     
Hematoma  1  1/150 (0.67%)  1 0/150 (0.00%)  0
Hot flashes  1  1/150 (0.67%)  1 0/150 (0.00%)  0
Hypertension  1  0/150 (0.00%)  0 1/150 (0.67%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Marie E. Wood, M.D
Organization: University of Vermont
Phone: 802-656-5452
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01224678     History of Changes
Other Study ID Numbers: CALGB-70806
CALGB-70806
CDR0000687263 ( Registry Identifier: NCI Physician Data Query )
First Submitted: October 19, 2010
First Posted: October 20, 2010
Results First Submitted: March 6, 2017
Results First Posted: June 25, 2018
Last Update Posted: June 25, 2018