Improving Vitamin D Status in Home-bound Elders (MOW VitD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01410084|
Recruitment Status : Completed
First Posted : August 4, 2011
Results First Posted : September 9, 2019
Last Update Posted : September 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Vitamin D Deficiency Accidental Falls||Dietary Supplement: Vitamin D3 Dietary Supplement: Vitamin E||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Improving Vitamin D Status in Home-bound Elders: a Pilot Study|
|Actual Study Start Date :||October 2010|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
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
- 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.
- 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)
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01410084
|United States, North Carolina|
|Wake Forest University|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Denise K Houston, PhD||Wake Forest University|