Mode
Text Size
Log in / Sign up
N/A N=68 Randomized Single-blind Treatment

Improving Vitamin D Status in Home-bound Elders

Vitamin D Deficiency · Accidental Falls

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

Back to search