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NCT01410084 · ClinicalTrials.gov registry record · NA
Improving Vitamin D Status in Home-bound Elders
A NA study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- NA
- Development phase
- 68
- Enrollment target
NCT01410084: Completed NA study, sponsored by Wake Forest University Health Sciences.
NCT01410084 is a NA study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 68 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01410084, a NA study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 68 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DIETARY_SUPPLEMENT Vitamin D3
- DIETARY_SUPPLEMENT Vitamin E
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2010-10 |
| Est. Completion | 2011-08 |
| Phase | NA |
What the finished NCT01410084 record still lists
NCT01410084 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Vitamin D3 is the first listed.
NCT01410084 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01410084 about?
NCT01410084 is a clinical study titled "Improving Vitamin D Status in Home-bound Elders". 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...
What is the current status of trial NCT01410084?
This trial is currently completed. It is a NA study. The enrollment target is 68 participants. The study started on 2010-10. Estimated completion is 2011-08.
What interventions are being tested in trial NCT01410084?
The interventions under investigation include: Vitamin D3 (DIETARY_SUPPLEMENT), Vitamin E (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01410084?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01410084's enrollment target sits among peer trials
68 1133rd of 2000 higher than 862 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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