Vitamin D as a Supplement Against Falls in Elderly Study (D-SAFE)

Effects of Vitamin D Supplementation on Fall Risk and Functional Outcomes in Older Adults With Insufficient Vitamin D Levels: A Pilot 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. 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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency (10 ng/mL to 30 ng/mL)
• Intervention / Treatment: Dietary supplement: Vitamin D

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 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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • Institute on Aging; University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vitamin D; Participants will take the Institute of Medicine's recommended daily dose of vitamin D (800 IU/day) for six months.	Dietary supplement: Vitamin D; Participants will take the Institute of Medicine's recommended daily dose of vitamin D (800 IU/day) for six months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Falls	Assess the change in number of falls participants have after taking vitamin D for six months.	Change in 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six Minute Walk Test	Assess the change in gait speed on the Six Minute Walk Test after taking vitamin D for six months.	Change in 6 Months
Short Physical Performance Battery (SPPB)	Assess the change in functional performance on the SPPB after taking vitamin D for six months.	Change in 6 Months
Grip Strength	Assess the change in grip strength after taking vitamin D for six months.	Change in 6 Months
Weight	Assess the change in weight after taking vitamin D for six months.	Change in 6 Months
Waist Circumference	Assess the change in waist circumference after taking vitamin D for six months.	Change in 6 Months
Perceived Level of Functioning as Measured by the Activity Measure for Post-Acute Care (AM-PAC)	Assess the change in perceived level of functioning as measured by the Activity Measure for Post-Acute Care (AM-PAC) after taking vitamin D for six months.	Change in 6 Months
Medical Outcomes Study Short-Form Health Survey (SF-36)	Assess the change in health-related quality of life after taking vitamin D for six months.	Change in 6 Months
Microbiome in the Human Colon	Assess the change in microbiome in the human colon after taking vitamin D for six months. Analyses of changes in bacterial diversity will be accomplished by deep sequencing of the ribosomal RNA, a highly conserved molecule that is used to classify bacteria.	Change in 6 Months
Microbiome in the Human Mouth	Assess the change in microbiome in the human mouth after taking vitamin D for six months. Analyses of changes in bacterial diversity will be accomplished by deep sequencing of the ribosomal RNA, a highly conserved molecule that is used to classify bacteria.	Change in 6 Months

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Stephen D Anton, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: April 4, 2013
• First Submitted That Met QC Criteria: April 4, 2013
• First Posted (Estimate): April 9, 2013

Study Record Updates

• Last Update Posted (Estimate): December 26, 2016
• Last Update Submitted That Met QC Criteria: December 23, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Balance; Vitamin D; Physical Function; Falls
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: 31-2013; 00085737-8 (Other Identifier: University of Florida)