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 @ 4:25 PM
Ignite Modification Date:
2025-12-24 @ 4:25 PM
NCT ID:
NCT02445066
Eligibility Criteria:
Inclusion Criteria:
* SPPB score of 10 or less
* initial serum 25(OH)D concentration of 12-17.9 ng/mL
* not dependent on a walker
* willing to provide informed consent and to adhere to the protocol
* not involved in another behavioral, exercise, or investigational drug intervention study
* self-reported physical performance difficulty
* were screened for the EVIDENCE study within the last 2 months
Exclusion Criteria:
* serious or uncontrolled chronic disease
* evidence of impaired cognitive function (MoCA\<18)
* taking prescription vitamin D2 or taking \>1000 IU/day of vitamin D3 from all sources; taking an oral corticosteroid; taking hormone replacement therapy
* inability or contraindications to consume daily vitamin D supplements
* knee or hip surgery within the last 6 months or planned knee or hip surgery within the next year
* not willing or eligible to undergo a muscle biopsy (on blood thinners)
* weight loss of greater than or equal to 5% in the past 3 months
* BMI \> 40kg/m2
* eye surgery within the past month or planned within the next month
* if the PI feels the participant is unlikely to follow the protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Maximum Age:
89 Years
Study:
NCT02445066
Study Brief:
Protocol Section:
NCT02445066