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:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-24 @ 9:40 PM
NCT ID:
NCT01904032
Eligibility Criteria:
Inclusion Criteria:
* Women age 21 and older
* Objective evidence of depressive symptoms at the screening and baseline visits
* Diagnosis of type 2 diabetes currently being treated by a healthcare provider
* Blood vitamin D level less than 32 nanograms-per-deciliter (32 ng/dl)
Exclusion Criteria:
* Current alcohol or substance use disorder
* Any unstable or severe psychiatric disease including diagnoses of schizophrenia, bipolar affective disorder, dementia, delirium, or other psychotic disorder
* Severe complications of diabetes, such as blindness and/or amputation
* Any malabsorption disorder, such as Crohn's disease and/or celiac sprue
* Elevated serum calcium level deemed significant by the Principal Investigator
* Use of 1,000 or more international units daily vitamin D 60 days before enrollment and unwillingness to discontinue vitamin D supplementation 30 days before enrollment.
* Use of St. John's Wort and unwillingness to discontinue St. John's Wort three weeks prior to enrollment.
* Participants who are pregnant, nursing, or planning to become pregnant during the study.
* Baseline systolic blood pressure (SBP) greater than 160 millimeters of mercury (mmHG) or diastolic blood pressure (DBP) greater than 100 mmHG.
* Other serious medical conditions (e.g., cancer, multiple sclerosis, etc.) deemed clinically significant by the Principal Investigator
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Study:
NCT01904032
Study Brief:
Protocol Section:
NCT01904032