Vitamin D Supplementation in Older Adults With Urinary Incontinence

Vitamin D Deficiency Clinical Trial

Official title:

Vitamin D Supplementation in Older Adults With Urinary Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01971801
• Other study ID #: VAMC11
• Status: Completed
• Phase: N/A
• First received: October 17, 2013
• Last updated: March 7, 2018
• Start date: January 2014
• Est. completion date: November 2017

Study information

• Verified date: March 2018
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: November 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Vitamin D3 50,000 IU
Capsule given by mouth once a week

Other:
• Placebo
One capsule given by mouth weekly

Locations

Country	Name	City	State
United States	UAB Continence Clinic at The Kirklin Clinic	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

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