Improving Vitamin D Status in Home-bound Elders

Not Applicable

Completed

Conditions: Vitamin D Deficiency
Accidental Falls

Interventions: Dietary Supplement: Vitamin E
Dietary Supplement: Vitamin D3

Registration Number: NCT01410084

Lead Sponsor: Wake Forest University Health Sciences

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 68

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin E	Vitamin E	400 IU vitamin E once monthly
Vitamin D3	Vitamin D3	100,000 IU vitamin D3 once monthly

Primary Outcome Measures

Name	Time	Method
Change in 25-hydroxyvitamin D Levels Over 5 Months	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 Outcome Measures

Name	Time	Method
Number of Falls	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)
Number of Participants Who Were Compliant to Intervention	5 months	Number of participants who consumed at least 4 out of a possible 5 supplement doses (=\>80% compliance) over 5 months.