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NCT01971801 · ClinicalTrials.gov registry record · NA
Vitamin D Supplementation in Older Adults With Urinary Incontinence
A NA study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- NA
- Development phase
- 243
- Enrollment target
NCT01971801: Completed NA study, sponsored by University of Alabama at Birmingham.
NCT01971801 is a NA study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 243 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01971801, a NA study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- NA
- Development phase
- 243 participants
- Enrollment target
Study Summary
Urinary incontinence (UI) is a common disorder among older women that greatly affects quality of life. Emerging evidence from observational studies links vitamin D insufficiency with UI. Prior to a larger intervention trial of vitamin D among older women with low serum vitamin D levels and urgency UI, we propose a pilot study in 100 older women comparing weekly, oral vitamin D3 50,000 IU to placebo. We hypothesize that adequate vitamin D supplementation will improve UI symptoms in older women with vitamin D deficiency. Changes in UI-episodes will be assessed by a 7-day bladder diary and other validated symptom measures administered at baseline and after 12-weeks of intervention. Serum calcium and 25(OH)D levels will be monitored. The expected outcomes will provide new knowledge regarding the impact of vitamin D supplementation on UI symptom improvement and inform a larger, randomized controlled clinical trial involving vitamin D supplementation.
Primary Outcome
The primary outcome measure is the percentage change in the number of incontinent episodes on a 7-day bladder diary from the baseline evaluation to the final visit at 12-weeks.
Interventions
- OTHER Placebo
- DIETARY_SUPPLEMENT Vitamin D3 50,000 IU
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 243 participants |
| Start Date | 2014-01 |
| Est. Completion | 2017-11 |
| Phase | NA |
What the finished NCT01971801 record still lists
NCT01971801 is an interventional study that assigns participants to a tested intervention. The registered 243 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01971801 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01971801 about?
NCT01971801 is a clinical study titled "Vitamin D Supplementation in Older Adults With Urinary Incontinence". Urinary incontinence (UI) is a common disorder among older women that greatly affects quality of life. Emerging evidence from observational studies links vitamin D insufficiency with UI. Prior to a larger intervention trial of vitamin D among older women with low serum vitamin D levels and urgency U...
What is the current status of trial NCT01971801?
This trial is currently completed. It is a NA study. The enrollment target is 243 participants. The study started on 2014-01. Estimated completion is 2017-11.
What interventions are being tested in trial NCT01971801?
The interventions under investigation include: Placebo (OTHER), Vitamin D3 50,000 IU (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01971801?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01971801's enrollment target sits among peer trials
243 438th of 2000 higher than 1,562 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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