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 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT02416193
Eligibility Criteria:
Inclusion Criteria:
* Women and men aged 18 to 75 years
* Have type 2 diabetes
* Having a subjective complaint of a cognitive dysfunction or scoring at least one standard deviation below normal on a cognitive functioning screening test
* Vitamin D level as measured by 25-hydroxyvitamin D (25-OH D) \< 32 ng/mL
* Under the care of a healthcare provider
* Systolic blood pressure ≤160 and diastolic blood pressure ≤100
Exclusion Criteria:
* Persons with malabsorption problems (e.g., crohn's disease)
* Hypercalcemia
* Supplementation other than a daily multivitamin
* Severe complications of diabetes (i.e., amputation, blindness, and dialysis)
* Concomitant use of steroids
* GFR \< 60
* Creatinine \> 1.2
* Significant depressive symptoms
* Having a history of bipolar depression, psychotic disorders, loss of consciousness greater than 5 minutes, or a current alcohol or substance use disorder
* Other serious medical conditions deemed significant by the PI or medical monitor
* Concomitant use of cholinesterase inhibitors
* Concomitant use of anxiolytics, kava kava, St. John's Wort, or Ginkgo Biloba
* Pregnancy
* HbA1c \>13%
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02416193
Study Brief:
Protocol Section:
NCT02416193