Vitamin D as a Supplement Against Falls in Elderly Study

The role of vitamin D deficiency on increased risk for falls and physical dysfunction is
unclear. It is also unclear if taking vitamin D improves physical function and reduces fall
risk in older adults. This study will look at the potential effects of taking vitamin D
regularly on falls and physical function in older adults. A total of 50 individuals with low
vitamin D levels (i.e., serum 25-hydroxy Vitamin D range 10 ng/mL to 30 ng/mL) and a recent
fall history will be enrolled into a six-month study. During the 6 months in this study,
participants will receive capsules containing 800 IU vitamin D, in non-childproof bottles,
for two 3-month periods. Participants will be asked to consume one capsule per day for the
duration of this six-month study, as well as attend four study visits: Screening Visit,
Baseline Visit, 3-Month Visit (in approximately 3 months from the baseline visit), and
6-Month Visit (in approximately 6 months from the baseline visit). During the screening
visit, participants will fill out questionnaires, complete the mini-mental status exam, have
their blood pressure and pulse taken, and a small sample of blood will be drawn from their
vein. During the baseline visit, participants will fill out questionnaires, have their blood
pressure, pulse, height, weight, and waist circumference taken, and perform several measures
of physical function. Finally, a mouth swab will be performed and a staff member will
collect a stool sample that you brought to the study visit. During the 3-Month Visit,
participants will complete a questionnaire and have their blood pressure and pulse taken.
During the 6-Month Visit, participants will repeat the questionnaires and measures that they
performed during the Baseline Visit. The investigators hypothesize that the participants
will experience fewer falls and function better physically after taking vitamin D for six
months.

Inclusion Criteria:

- Age ≥ 70 years

- Serum 25-hydroxy vitamin D >10 ng/mL and < 30 ng/mL

- Having had a fall at least twice in the past six months

- Provide informed consent

Exclusion Criteria:

- Failure to provide informed consent

- Self-reported myocardial infarction, cerebrovascular accident, or unstable angina
within the past 6 months; New York Heart Association (NYHA) Class 3 or 4 congestive
heart failure; aortic stenosis; chronic hepatitis; cirrhosis; kidney disease; solid
organ transplantation; major psychiatric disorder; history of kidney stones or
history of renal colic; history of nephrotic syndrome; history of primary
hyperparathyroidism or renal tubular acidosis; history of hypercalcemia; cancer
requiring treatment in the past three years, except for non-melanoma skin cancers or
cancers that have clearly been cured or in the opinion of the investigator carry an
excellent prognosis (e.g., Stage 1 cervical cancer);

- Other significant co-morbid disease (e.g. renal failure on hemodialysis) or severe
psychiatric disorder (e.g. bipolar, schizophrenia) that would impair ability to
participate in the exercise-based intervention

- Cognitive impairment (i.e., Mini Mental Status Exam score < 23) or history of
significant head injury

- Current use of anabolic medications (i.e., growth hormones or testosterone),
antidepressant medications, antipsychotic agents, monoamine oxidase inhibitors,
anticholinesterase inhibitors (i.e., Aricept), anticoagulant therapies (aspirin use
is permitted), or antibiotics for HIV or tuberculosis

- Dietary supplementation with > 800 IU/day of Vitamin D

- Hypercalcemia (calcium > 10.4 mg/dL), hypocalcemia (calcium < 8.6 mg/dL), or renal
insufficiency (estimated glomerular filtration rate (GFR) < 50 ml/min)

- Serum aspartate (AST) or alanine transaminase (ATL) >3 times upper limit normal (UPN)

- High amounts of physical activity (i.e. running or bicycling) > 120 min/week

- Excessive alcohol use ( >14 drinks per wk )

- History of drug or alcohol abuse (i.e., more than 5 drinks/day for males or more than
4 drinks/day for females)

- Planning to leave the area in the next year

- Resting heart rate > 120 bpm

- Systolic blood pressure > 180 mmHg

- Diastolic blood pressure > 100 mmHg

- Vision or hearing impairment

- Participating in another clinical trial or has received an investigational product
within 30 days prior to screening/enrollment