Status:
COMPLETED
Vitamin D as a Supplement Against Falls in Elderly Study
Lead Sponsor:
University of Florida
Conditions:
Vitamin D Deficiency (10 ng/mL to 30 ng/mL)
Eligibility:
All Genders
70+ years
Phase:
NA
Brief Summary
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 adult...
Detailed Description
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 adult...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01827345
Start Date
April 1 2013
End Date
December 1 2016
Last Update
December 26 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Institute on Aging; University of Florida
Gainesville, Florida, United States, 32611