Principal research objective
- To conduct a clinical trial to determine which of four doses of vitamin D pills is the best dose for the prevention of falls in ~1,200 older adults, who are at risk of falling and who have a low serum vitamin D level (10-25 ng/mL)
Sponsor
- National Institute on Aging (NIA) of the National Institutes of Health (NIH)
Study population
- Adults, ages 70 and older, who are at high risk for falling
Main inclusion criteria
At least one of the following:
- Two or more falls in the past year
- One fall with injury in the past year
- Fear of falling because of balance or walking problems
- Difficulty maintaining balance when bathing, dressing, or getting in and out of a chair
- Use of a cane, walker, or other device
- Serum vitamin D level of 10-25 ng/mL (we will measure this)
- Average daily vitamin D supplementation <1,000 IU
- Average daily calcium supplementation <1,200 mg
Vitamin D doses to be tested
- 200 IU per day
- 1,000 IU per day
- 2,000 IU per day
- 4,000 IU per day
Outcomes
- Falls
- Physical function (gait speed, balance, muscle strength)
Participant experience
- Eligibility assessments (over the phone and in-person)
- In-person visits at 3, 12, and 24 months after joining at ProHealth in Baltimore (Woodlawn) or the Comstock Center in Hagerstown (both are Johns Hopkins research clinics). Visits will include questionnaires, physical performance tests, and a blood draw.
- Telephone calls between in-person visits
- Pill-taking - one small pill every day
- Fall diary completion
Benefits/risks
- Risk is minimal
- Benefits include free tests and health information
Timeline
- Recruitment and screening began June 2015
