N/A
N=68
Improving Vitamin D Status in Home-bound Elders
Vitamin D Deficiency · Accidental Falls
Bottom Line
View on ClinicalTrials.gov: NCT01410084 ↗Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Change in 25-hydroxyvitamin D Levels Over 5 Months — 21.7; 0 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Vitamin D3 (Dietary_supplement); Vitamin E (Dietary_supplement)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in 25-hydroxyvitamin D Levels Over 5 Months |
21.7; 0 | — |
| SECONDARY Number of Falls |
0.5; 1.1 | — |
| SECONDARY Number of Participants Who Were Compliant to Intervention |
37; 24 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01410084). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.