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Improving Vitamin D Status in Home-bound Elders (MOW VitD)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Wake Forest University
ClinicalTrials.gov Identifier:
NCT01410084
First received: August 3, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

In the past two decades, the role of vitamin D has extended beyond bone health to encompass a wide range of biological activities important to physical function in older adults. A growing body of evidence now shows that circulating 25-hydroxyvitamin D (25(OH)D) levels < 75 nmol/L (< 30 ng/mL)) are associated with physical impairments such as reduced walking speed and impaired balance as well as falls. Older adults are at risk for low levels of 25-hydroxyvitamin D because of reduced exposure to ultraviolet B radiation, reduced efficiency of previtamin D synthesis in the skin, and low dietary intake. Although data from the National Health and Nutrition Examination Survey (NHANES) 2000-2004 indicate that frank vitamin D deficiency (serum 25(OH)D < 25 nmol/L [10 ng/mL]) is rare in the U.S. (5% or less), vitamin D insufficiency (serum 25(OH)D < 75 nmol/L [30 ng/mL]) is prevalent (~75%) among older adults. Older home-bound adults are a vulnerable subgroup of older adults for poor dietary intake and nutritional health, nutrition-related health conditions, and functional decline and disability. The primary goal of this pilot study is to assess the feasibility of a partnership with Senior Services of Forsyth County to address vitamin D insufficiency in home-bound older adults receiving home-delivered meals. A secondary goal is to obtain preliminary data on the effectiveness of vitamin D supplementation on improving vitamin D levels and reducing falls.


Condition Intervention
Vitamin D Deficiency
Accidental Falls
 Dietary Supplement: Vitamin D3
Dietary Supplement: Vitamin E

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Improving Vitamin D Status in Home-bound Elders: a Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wake Forest University:

Primary Outcome Measures:
  • Change in 25-hydroxyvitamin D levels [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    Determine the effectiveness of the intervention on improving 25-hydroxyvitamin D levels (change in 25(OH)D from baseline to 5-month follow-up)


Secondary Outcome Measures:
  • Number of falls [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    Determine the effectiveness of the intervention on reducing the number of falls using monthly fall calendars (compare the average number of falls in vitamin D3 group vs. active placebo group over 5 months)

  • Measure compliance to intervention [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    Determine number of supplement doses received over 5 months


Estimated Enrollment: 200
Study Start Date: October 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D3
100,000 IU vitamin D3 once monthly
 Dietary Supplement: Vitamin D3
100,000 IU vitamin D3 once monthly for 5 months
Placebo Comparator: Vitamin E
400 IU vitamin E once monthly
 Dietary Supplement: Vitamin E
400 IU vitamin E once monthly for 5 months

Detailed Description:

In the past two decades, the role of vitamin D has extended beyond bone health to encompass a wide range of biological activities important to physical function in older adults. A growing body of evidence now shows that circulating 25-hydroxyvitamin D (25(OH)D) levels < 75 nmol/L (< 30 ng/mL)) are associated with physical impairments such as reduced walking speed and impaired balance as well as falls. Older adults are at risk for low levels of 25-hydroxyvitamin D because of reduced exposure to ultraviolet B radiation, reduced efficiency of previtamin D synthesis in the skin, and low dietary intake. Although data from the National Health and Nutrition Examination Survey (NHANES) 2000-2004 indicate that frank vitamin D deficiency (serum 25(OH)D < 25 nmol/L [10 ng/mL]) is rare in the U.S. (5% or less), vitamin D insufficiency (serum 25(OH)D < 75 nmol/L [30 ng/mL]) is prevalent (~75%) among older adults. Older home-bound adults are a vulnerable subgroup of older adults for poor dietary intake and nutritional health, nutrition-related health conditions, and functional decline and disability. The primary goal of this pilot study is to assess the feasibility of a partnership with Senior Services of Forsyth County to address vitamin D insufficiency in home-bound older adults receiving home-delivered meals. The investigators will accomplish this goal by conducting a 5-month randomized, controlled trial in 200 older Meals-on-Wheels (MOW) recipients randomized to receive monthly either (1) 100,000 IU vitamin D3 or (2) an active placebo (vitamin E) to achieve the following specific aims:

Aim 1: Determine the prevalence of falls and risk of vitamin D insufficiency in 200 MOW recipients.

Aim 2: Assess the feasibility of the vitamin D intervention delivered through the MOW program.

Aim 3: Obtain preliminary data on the effectiveness of the intervention on improving vitamin D status and reducing falls.

Data from this pilot study will: 1) provide estimates of the prevalence of falls and vitamin D insufficiency in home-bound older adults participating in the Forsyth County MOW program; 2) provide estimates of participant compliance and drop-out to a vitamin supplementation trial delivered as part of the MOW program; 3) provide evidence for the efficacy of the vitamin D dose proposed in remediating vitamin D insufficiency; and 4) provide preliminary data on the potential benefit of vitamin D supplementation on falls in a home-bound older population.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 65 years old
  • Forsyth County Senior Services Meals-on-Wheels recipient
  • Willing to provide informed consent
  • Willing to be randomized to vitamin D or active placebo control

Exclusion Criteria:

  • Hyperparathyroidism
  • Kidney stones (within the past 2 years)
  • History of hypercalcemia
  • On dialysis
  • Inability or contraindications to consume vitamin D supplements
  • Taking prescription vitamin D2 or vitamin D3-containing supplements totaling > 1000 IU/d
  • Planning to move within the next 6 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01410084

Locations
United States, North Carolina
Wake Forest University
Winston Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University
Investigators
Principal Investigator: Denise K Houston, PhD Wake Forest University
  More Information

No publications provided

Responsible Party: Denise K. Houston, Wake Forest University
ClinicalTrials.gov Identifier: NCT01410084     History of Changes
Other Study ID Numbers: IRB#14152
Study First Received: August 3, 2011
Last Updated: August 3, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest University:
vitamin D
falls
deficiency
insufficiency

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamin E
Alpha-Tocopherol
Tocopherols
 Tocotrienols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on May 22, 2013