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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Denise K. Houston, PhD, RD, Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT01410084
First received: August 3, 2011
Last updated: November 14, 2013
Last verified: November 2013

August 3, 2011
November 14, 2013
October 2010
August 2011   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01410084 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Improving Vitamin D Status in Home-bound Elders
Improving Vitamin D Status in Home-bound Elders: a Pilot Study

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Vitamin D Deficiency
  • Accidental Falls
  • Dietary Supplement: Vitamin D3
    100,000 IU vitamin D3 once monthly for 5 months
  • Dietary Supplement: Vitamin E
    400 IU vitamin E once monthly for 5 months
  • Experimental: Vitamin D3
    100,000 IU vitamin D3 once monthly
    Intervention: Dietary Supplement: Vitamin D3
  • Placebo Comparator: Vitamin E
    400 IU vitamin E once monthly
    Intervention: Dietary Supplement: Vitamin E
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01410084
IRB#14152
Yes
Denise K. Houston, PhD, RD, Wake Forest School of Medicine
Wake Forest School of Medicine
Not Provided
Principal Investigator: Denise K Houston, PhD Wake Forest School of Medicine
Wake Forest School of Medicine
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP