Table 1:
STURDY 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: |
| ▪ Have you fallen and hurt yourself in the past year? |
| ▪ Have you fallen 2 or more times in the past year? |
| ▪ Are you afraid that you might fall because of balance or walking |
| problems? |
| ▪ Do you have difficulty maintaining your balance when bathing, dressing, or |
| getting in and out of a chair? |
| ▪ Do you use a cane, walker, or other device when walking inside or outside |
| your home? |
| ▪ Serum vitamin D [25(OH)D] concentration ≥10 and <30 ng/ml (≥25 and <75 |
| nmol/L) |
| ▪ Able to provide informed consent |
| ▪ Able to walk (with or without assistive device) |
| ▪ Willing to accept randomization to each vitamin D dose |
| ▪ One of the following: |
| ▪ No vitamin D supplementation at screening |
| ▪ Average daily vitamin D supplementation judged by study staff as being |
| consistent with the goal of ≤1000 IU/day at screening and willing to |
| continue the dose unchanged throughout the trial |
| ▪ One of the following: |
| ▪ No calcium supplementation at screening |
| ▪ Average daily calcium supplementation judged by study staff as being |
| consistent with the goal of ≤1200 mg/day at screening and willing to |
| continue the dose unchanged throughout the trial |
|
Exclusion Criteria |
| ▪ Cognitive impairment, defined as Mini-Mental State Exam (MMSE) score <24 |
| ▪ Hypercalcemia, serum Ca2+ >10.5 mg/dl (confirmed) |
| ▪ Hypocalcemia, serum Ca2+ <8.5 mg/dl |
| ▪ Kidney, ureteral, or bladder stones made of calcium compounds (≥2 in lifetime, or 1 |
| in the last 2 years); in the absence of information on 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®, Calcijex®, |
| and Zemplar®; generic names: calcitriol, paricalcitol, doxycalcitriol, 22- |
| oxacalcitriol) |