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Completed

NCT Number: NCT01410084

Improving Vitamin D Status in Home-bound Elders

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

About this 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. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D3

Dietary Supplement

100,000 IU vitamin D3 once monthly for 5 months

Vitamin E

Dietary Supplement

400 IU vitamin E once monthly for 5 months

Primary outcomes

  1. Change in 25-hydroxyvitamin D Levels Over 5 Months

    Time frame: 5 months

    Determine the effectiveness of the intervention on improving 25-hydroxyvitamin D levels (change in 25(OH)D from baseline to 5-month follow-up). Measured as 5-month follow-up 25(OH)D level minus baseline 25(OH)D level.

Secondary outcomes

  1. Number of Falls

    Time frame: 5 months

    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)

  2. Number of Participants Who Were Compliant to Intervention

    Time frame: 5 months

    Number of participants who consumed at least 4 out of a possible 5 supplement doses (=>80% compliance) over 5 months.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Improving Vitamin D Status in Home-bound Elders: a Pilot Study

Acronym: MOW VitD

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 4, 2011
Registry last updated
Sep 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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