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 @ 3:03 AM
Ignite Modification Date:
2025-12-25 @ 3:03 AM
NCT ID:
NCT02166333
Eligibility Criteria:
Inclusion Criteria:
* Age 70 and older
* Non-institutionalized
* High risk for falling, defined by a 'yes' response to at least one of the following:
* 1\. Have you fallen and hurt yourself in the past year?
* 2\. Have you fallen 2 or more times in the past year?
* 3\. Are you afraid that you might fall because of balance or walking problems?
* 4\. Do you have difficulty maintaining your balance when bathing, dressing, or getting in and out of a chair?
* 5\. Do you use a cane, walker, or other device when walking inside or outside your home?
* Serum vitamin D \[25(OH)D\] level of 10-29 ng/ml
* Able to provide informed consent
* Willing to accept randomization to each vitamin D dose
* One of the following:
* 1\. No vitamin D supplementation at baseline
* 2\. Average daily vitamin D supplementation judged by study staff as being consistent with the goal of 1000 IU/day or less at screening and willing to continue the dose unchanged throughout the trial
* One of the following:
* 1\. No calcium supplementation at baseline
* 2\. Average daily calcium supplementation judged by study staff as being consistent with the goal of 1200 mg/day or less at screening and willing to continue the dose unchanged throughout the trial
Exclusion Criteria:
* Cognitive impairment, defined by Mini-Mental State Exam (MMSE) score \<24
* Hypercalcemia, serum Ca++ 11.0 mg/dl or higher or \>10.5 mg/dl (confirmed)
* Hypocalcemia, serum Ca++ \<8.5 mg/dl
* Kidney, ureteral, or bladder stones made of calcium compounds (2 or more in lifetime, or 1 in the last 2 years); in the absence of information on the type of stone, stones will be assumed to be made of calcium compounds
* Planning to move out of area within 2 years, where plans would prevent compliance with the study protocol
* Disease or condition expected to cause death or to prevent compliance with the study protocol in the next 2 years
* Participation in another trial of vitamin D or falls, or any trial that might affect the risk of falls
* Lactose allergy (lactose intolerance is okay)
* Use of any form of oral or injected calcitriol (brand names: Rocaltrol (R), Calcijex (R), and Zemplar (R); generic names: calcitriol, paricalcitol, doxycalcitriol, 22-oxacalcitriol)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
70 Years
Study:
NCT02166333
Study Brief:
Protocol Section:
NCT02166333