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 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT01179503
Eligibility Criteria:
Inclusion Criteria:
* Short Physical Performance Battery (SPPB) score of ≥ 4 to \< 10
* Vitamin D insufficient (serum 25(OH)D ≥ 10 to \< 25 ng/mL)
Exclusion Criteria:
* Serious or uncontrolled chronic disease including: insulin-dependent or uncontrolled diabetes; cancer requiring treatment in past year, except non-melanoma skin cancers; past or current ischemic heart disease, uncontrolled angina, heart failure, peripheral artery disease (PAD), or stroke; chronic respiratory disease; uncontrolled endocrine/metabolic disease; neurological or hematological disease; liver or renal dysfunction; and severe musculoskeletal impairment
* Impaired cognitive function (MMSE ≤ 24)
* Dependent on a cane or walker
* Use of anti-coagulants
* Unwillingness to undergo a muscle biopsy
* Taking prescription vitamin D2 or OCT vitamin D3 supplements of \> 1000 IU/d
* Inability or contraindications to consume daily vitamin D and calcium supplements
* Weight loss of ≥ 5% or more in the past 6 months
* Involved in any other intervention
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
70 Years
Maximum Age:
89 Years
Study:
NCT01179503
Study Brief:
Protocol Section:
NCT01179503