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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01827345
First received: April 4, 2013
Last updated: October 14, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Vitamin D Deficiency (10 ng/mL to 30 ng/mL)
Dietary Supplement: Vitamin D

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Vitamin D Supplementation on Fall Risk and Functional Outcomes in Older Adults With Insufficient Vitamin D Levels: A Pilot Study

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Number of Falls [ Time Frame: Change in 6 months ] [ Designated as safety issue: No ]
    Assess the change in number of falls participants have after taking vitamin D for six months.


Secondary Outcome Measures:
  • Six Minute Walk Test [ Time Frame: Change in 6 Months ] [ Designated as safety issue: No ]
    Assess the change in gait speed on the Six Minute Walk Test after taking vitamin D for six months.

  • Short Physical Performance Battery (SPPB) [ Time Frame: Change in 6 Months ] [ Designated as safety issue: No ]
    Assess the change in functional performance on the SPPB after taking vitamin D for six months.

  • Grip Strength [ Time Frame: Change in 6 Months ] [ Designated as safety issue: No ]
    Assess the change in grip strength after taking vitamin D for six months.

  • Weight [ Time Frame: Change in 6 Months ] [ Designated as safety issue: No ]
    Assess the change in weight after taking vitamin D for six months.

  • Waist Circumference [ Time Frame: Change in 6 Months ] [ Designated as safety issue: No ]
    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) [ Time Frame: Change in 6 Months ] [ Designated as safety issue: No ]
    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) [ Time Frame: Change in 6 Months ] [ Designated as safety issue: No ]
    Assess the change in health-related quality of life after taking vitamin D for six months.

  • Microbiome in the Human Colon [ Time Frame: Change in 6 Months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change in 6 Months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: April 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01827345

Contacts
Contact: Stephen D Anton, PhD 352-273-7514 santon@ufl.edu
Contact: Jane Lu, MS 352-294-5853 janelu@ufl.edu

Locations
United States, Florida
Institute on Aging; University of Florida Recruiting
Gainesville, Florida, United States, 32611
Contact    866-386-7730      
Contact    352-273-7514      
Principal Investigator: Stephen D Anton, PhD         
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Stephen D Anton, PhD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01827345     History of Changes
Other Study ID Numbers: 31-2013, 00085737-8
Study First Received: April 4, 2013
Last Updated: October 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Vitamin D
Falls
Balance
Physical Function

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 19, 2014