CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 68 enrolled
Drug / intervention
Vitamin D3 +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01410084
NCT01410084N/ACompleted

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

Wake Forest University Health Sciences·interventional·Posted Aug 4, 2011·Updated Sep 9, 2019

In Brief

A clinical study evaluating Vitamin D3 and Vitamin E for Vitamin D Deficiency and Accidental Falls. Completed, enrolled 68 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 4, 2011
Enrollment StartOct 1, 2010
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 14.9 years ago

Interventions

Vitamin D3dietary

100,000 IU vitamin D3 once monthly for 5 months

Vitamin Edietary

400 IU vitamin E once monthly for 5 months