Clinical trial NCT01971801: Vitamin D Supplementation in Older Adults With Urinary Incontinence
Official title: Vitamin D Supplementation in Older Adults With Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Vitamin D Deficiency
Keywords: urinary incontinence
bowel incontinence
vitamin D
overactive bladder
lower urinary tract symptoms
quality of life
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2013-10-29
Enrollment: 243
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Change in the number of incontinent episodes on a 7-day bladder diary
timeFrame: baseline to 12 weeks
Secondary outcomes:
measure: Change in UI symptoms (ICIQ-UI and ICIQ-OAB scores)
timeFrame: baseline to 12 weeks
measure: Change in quality of life (Overactive Bladder Questionnaire)
timeFrame: baseline to 12 weeks
measure: Change in satisfaction with treatment (Perceptions and Satisfaction Questionnaire)
timeFrame: baseline to 12 weeks
measure: Change in safety of the treatments (side effects and unanticipated events)
timeFrame: baseline to 12 weeks
measure: Mechanisms of improvement based on measure of mobility
timeFrame: baseline to 12 weeks
measure: Bowel incontinence symptoms
timeFrame: baseline to 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Continence Clinic at The Kirklin Clinic
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Alayne D Markland, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Markland AD, Tangpricha V, Mark Beasley T, Vaughan CP, Richter HE, Burgio KL, Goode PS. Comparing Vitamin D Supplementation Versus Placebo for Urgency Urinary Incontinence: A Pilot Study. J Am Geriatr Soc. 2019 Mar;67(3):570-575. doi: 10.1111/jgs.15711. Epub 2018 Dec 21.