Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-25 @ 4:13 AM
NCT ID:
NCT01747720
Eligibility Criteria:
Inclusion Criteria:
* be premenopausal at baseline;
* have breast density of at least 20% at baseline;
* have normal baseline serum calcium (2,12-2,60 mmol/L) and serum creatinine (45-85 μmol/L);
* agree to have her mammogram at 12 months of follow-up at the same mammography clinic (same site) as the one where the mammogram at recruitment was done.
Exclusion Criteria:
* taking \> 400 IU/day of supplemental vitamin D and refusing to reduce (≤ 400 IU/day) or cease such intake;
* taking \> 600 mg/day of supplemental calcium and refusing to reduce (≤ 600 mg/day) or cease such intake;
* have contra-indications for use of vitamin D supplementation (hypersensitivity to vitamin D or its analogues; a history of renal calculi or hypercalcemia, hypervitaminosis D);
* taking medication suspected to interact with vitamin D: frequent use of antacids containing magnesium or aluminium; regular use of anticonvulsants (phenytoin, phenobarbital), digoxin, cholestyramine, colestipol, orlistat, mineral oil;
* have a personal history of breast cancer;
* have a personal history of cancer other than non-melanoma skin cancer within 5 last years;
* have had breast reduction or augmentation including breast implantation (or planning to undergo such surgery during the trial);
* be pregnant or planning a pregnancy in the next year.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01747720
Study Brief:
Protocol Section:
NCT01747720