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Vitamin D Supplementation in Older Adults With Urinary Incontinence

Not Applicable
Completed
Conditions
Urinary Incontinence
Vitamin D Deficiency
Interventions
Other: Placebo
Dietary Supplement: Vitamin D3 50,000 IU
Registration Number
NCT01971801
Lead Sponsor
University of Alabama at Birmingham
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
243
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.

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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).

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlaceboPlacebo comparator, weekly
Vitamin DVitamin D3 50,000 IUVitamin D3, 50,000 IU, weekly
Primary Outcome Measures
NameTimeMethod
Change in the number of incontinent episodes on a 7-day bladder diarybaseline to 12 weeks

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.

Secondary Outcome Measures
NameTimeMethod
Change in UI symptoms (ICIQ-UI and ICIQ-OAB scores)baseline to 12 weeks

Questionnaires

Change in safety of the treatments (side effects and unanticipated events)baseline to 12 weeks

Checklist

Change in satisfaction with treatment (Perceptions and Satisfaction Questionnaire)baseline to 12 weeks

Questionnaire

Mechanisms of improvement based on measure of mobilitybaseline to 12 weeks

Physical examination

Bowel incontinence symptomsbaseline to 12 weeks

Questionnaire

Change in quality of life (Overactive Bladder Questionnaire)baseline to 12 weeks

Questionnaires

Trial Locations

Locations (1)

UAB Continence Clinic at The Kirklin Clinic

🇺🇸

Birmingham, Alabama, United States

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