Back to resultsVitamin D as a Supplement Against Falls in Elderly Study (D-SAFE)
Primary Purpose
Vitamin D Deficiency (10 ng/mL to 30 ng/mL)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin D
Sponsored by
About this trial
This is an interventional treatment trial for Vitamin D Deficiency (10 ng/mL to 30 ng/mL) focused on measuring Vitamin D, Falls, Balance, Physical Function
Eligibility Criteria
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
Sites / Locations
- Institute on Aging; University of Florida
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vitamin D
Arm Description
Participants will take the Institute of Medicine's recommended daily dose of vitamin D (800 IU/day) for six months.
Outcomes
Primary Outcome Measures
Number of Falls
Assess the change in number of falls participants have after taking vitamin D for six months.
Secondary Outcome Measures
Six Minute Walk Test
Assess the change in gait speed on the Six Minute Walk Test after taking vitamin D for six months.
Short Physical Performance Battery (SPPB)
Assess the change in functional performance on the SPPB after taking vitamin D for six months.
Grip Strength
Assess the change in grip strength after taking vitamin D for six months.
Weight
Assess the change in weight after taking vitamin D for six months.
Waist Circumference
Assess the change in waist circumference after taking vitamin D for six 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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01827345
Brief Title
Vitamin D as a Supplement Against Falls in Elderly Study
Acronym
D-SAFE
Official Title
Effects of Vitamin D Supplementation on Fall Risk and Functional Outcomes in Older Adults With Insufficient Vitamin D Levels: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency (10 ng/mL to 30 ng/mL)
Keywords
Vitamin D, Falls, Balance, Physical Function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D
Arm Type
Experimental
Arm Description
Participants will take the Institute of Medicine's recommended daily dose of vitamin D (800 IU/day) for six months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Intervention Description
Participants will take the Institute of Medicine's recommended daily dose of vitamin D (800 IU/day) for six months.
Primary Outcome Measure Information:
Title
Number of Falls
Description
Assess the change in number of falls participants have after taking vitamin D for six months.
Time Frame
Change in 6 months
Secondary Outcome Measure Information:
Title
Six Minute Walk Test
Description
Assess the change in gait speed on the Six Minute Walk Test after taking vitamin D for six months.
Time Frame
Change in 6 Months
Title
Short Physical Performance Battery (SPPB)
Description
Assess the change in functional performance on the SPPB after taking vitamin D for six months.
Time Frame
Change in 6 Months
Title
Grip Strength
Description
Assess the change in grip strength after taking vitamin D for six months.
Time Frame
Change in 6 Months
Title
Weight
Description
Assess the change in weight after taking vitamin D for six months.
Time Frame
Change in 6 Months
Title
Waist Circumference
Description
Assess the change in waist circumference after taking vitamin D for six months.
Time Frame
Change in 6 Months
Title
Perceived Level of Functioning as Measured by the Activity Measure for Post-Acute Care (AM-PAC)
Description
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.
Time Frame
Change in 6 Months
Title
Medical Outcomes Study Short-Form Health Survey (SF-36)
Description
Assess the change in health-related quality of life after taking vitamin D for six months.
Time Frame
Change in 6 Months
Title
Microbiome in the Human Colon
Description
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.
Time Frame
Change in 6 Months
Title
Microbiome in the Human Mouth
Description
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.
Time Frame
Change in 6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen D Anton, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute on Aging; University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
12. IPD Sharing Statement
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Vitamin D as a Supplement Against Falls in Elderly Study
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