Vitamin D as a Supplement Against Falls in Elderly Study

Completed · Not applicable

Conditions studied: Vitamin D Deficiency (10 ng/mL to 30 ng/mL)

In brief

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. The purpose of this research study is to explore the effects of taking the recommended dose of vitamin D (800 IUs/day) for six months on fall risk and physical functional outcomes in older adults with low vitamin D levels. The investigators hypothesize that the participants will experience fewer falls and function better physically after taking vitamin D for six months.

Key facts

Study ID

NCT01827345

Run by

University of Florida

People needed

25

Starts

2013-04-01

Expected to finish

2016-12-01

Last updated by the study team

2016-12-26

Who can join

Age: 70 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Institute on Aging; University of Florida — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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