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 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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence; Vitamin D Deficiency
• Intervention / Treatment: Dietary supplement: Vitamin D3 50,000 IU; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 243
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • UAB Continence Clinic at The Kirklin Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vitamin D; Vitamin D3, 50,000 IU, weekly	Dietary supplement: Vitamin D3 50,000 IU; Capsule given by mouth once a week
Placebo Comparator: Placebo; Placebo comparator, weekly	Other: Placebo; One capsule given by mouth weekly; Other Names: Capsule placebo

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Alayne D Markland, DO, University of Alabama at Birmingham

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: October 17, 2013
• First Submitted That Met QC Criteria: October 23, 2013
• First Posted (Estimate): October 29, 2013

Study Record Updates

• Last Update Posted (Actual): March 9, 2018
• Last Update Submitted That Met QC Criteria: March 7, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: quality of life; overactive bladder; vitamin D; urinary incontinence; lower urinary tract symptoms; bowel incontinence
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Nutrition Disorders; Urination Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Elimination Disorders; Urinary Incontinence; Vitamin D Deficiency; Enuresis; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: VAMC11