Vitamin D Supplementation in Older Adults With Urinary Incontinence

Study Overview
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Brief Summary
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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.

Official Title
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Vitamin D Supplementation in Older Adults With Urinary Incontinence

Conditions
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Urinary Incontinence, Vitamin D Deficiency

Intervention / Treatment
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* Dietary Supplement: Vitamin D3 50,000 IU
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (1) Post-menopausal women (age ≥50 years of age); (2)Urine leakage for 3 or more months; (3) at least 3 urinary urgency incontinence episodes on a 7-day bladder diary; and (4) serum 25(OH)D level (vitamin D) is <30 ng/mL. Women who currently take a bladder medications (anticholinergic) for UI symptom control may enroll into the study if they agree to (1) cease taking these medications at least two weeks before the pre-intervention assessment and (2) not take these medications during the study's treatment and assessment period. Exclusion Criteria: (1) neurologic diseases known to affect UI; (2) Diseases known to affect vitamin D absorption and metabolism; (3) Prior pelvic floor radiation; (4) Obstructive causes of UI;(6)Current use of medications known to affect vitamin D levels; (7) Uncontrolled diabetes (Hemoglobin A1C>9%); (8) albumin corrected serum Calcium > 11.0 mg/dL; (9)history of hyperparathyroidism; (10) currently untreated kidney stones; (11) post void residual urine volume >200 ml; and, (12) current treatment with vitamin D >=1000IU/day (if not willing to stop taking).

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin D<br>Vitamin D3, 50,000 IU, weekly | Dietary Supplement: Vitamin D3 50,000 IU<br>* Capsule given by mouth once a week<br>|
| Placebo Comparator: Placebo<br>Placebo comparator, weekly | Other: Placebo<br>* One capsule given by mouth weekly<br>* Other names: Capsule placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the number of incontinent episodes on a 7-day bladder diary | 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. | baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in UI symptoms (ICIQ-UI and ICIQ-OAB scores) | Questionnaires | baseline to 12 weeks | 
| Change in quality of life (Overactive Bladder Questionnaire) | Questionnaires | baseline to 12 weeks | 
| Change in satisfaction with treatment (Perceptions and Satisfaction Questionnaire) | Questionnaire | baseline to 12 weeks | 
| Change in safety of the treatments (side effects and unanticipated events) | Checklist | baseline to 12 weeks | 
| Mechanisms of improvement based on measure of mobility | Physical examination | baseline to 12 weeks | 
| Bowel incontinence symptoms | Questionnaire | baseline to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urinary incontinence, bowel incontinence, vitamin D, overactive bladder, lower urinary tract symptoms, quality of life