Vitamin D as a Supplement Against Falls in Elderly Study

NCT01827345 | Completed DMC

• 2 other identifiers: 31-201300085737-8
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Vitamin D Deficiency (10 ng/mL to 30 ng/mL)

Keywords

Vitamin D; Falls; Balance; Physical Function

Outcome Measures

Primary Outcomes (1)

• Number of Falls

  Assess the change in number of falls participants have after taking vitamin D for six months.

  Change in 6 months

Secondary Outcomes (9)

• Six Minute Walk Test

  Change in 6 Months

• Short Physical Performance Battery (SPPB)

  Change in 6 Months

• Grip Strength

  Change in 6 Months

• Weight

  Change in 6 Months

• Waist Circumference

  Change in 6 Months

Study Arms (1)

Vitamin D

EXPERIMENTAL

Participants will take the Institute of Medicine's recommended daily dose of vitamin D (800 IU/day) for six months.

Dietary Supplement: Vitamin D

Interventions

Vitamin D DIETARY_SUPPLEMENT

Participants will take the Institute of Medicine's recommended daily dose of vitamin D (800 IU/day) for six months.

Vitamin D

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

Institute on Aging; University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Stephen D Anton, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2013
• First Posted: April 9, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 26, 2016

Record last verified: 2016-12

Locations

US (1)