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Vitamin D Supplementation in Older Adults With Urinary Incontinence

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by University of Alabama at Birmingham
Information provided by (Responsible Party):
University of Alabama at Birmingham Identifier:
First received: October 17, 2013
Last updated: August 26, 2016
Last verified: August 2016
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.

Condition Intervention Phase
Urinary Incontinence
Vitamin D Deficiency
Dietary Supplement: Vitamin D
Other: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vitamin D Supplementation in Older Adults With Urinary Incontinence

Resource links provided by NLM:

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Change in the number of incontinent episodes on a 7-day bladder diary [ Time Frame: baseline to 12 weeks ]
    The primary outcome measure is the 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:
  • Change in UI symptoms (ICIQ-UI and ICIQ-OAB scores) [ Time Frame: baseline to 12 weeks ]

  • Change in quality of life (Overactive Bladder Questionnaire) [ Time Frame: baseline to 12 weeks ]

  • Change in satisfaction with treatment (Perceptions and Satisfaction Questionnaire) [ Time Frame: baseline to 12 weeks ]

  • Change in safety of the treatments (side effects and unanticipated events) [ Time Frame: baseline to 12 weeks ]

  • Mechanisms of improvement based on measure of mobility [ Time Frame: baseline to 12 weeks ]
    Physical examination

  • Bowel incontinence symptoms [ Time Frame: baseline to 12 weeks ]

Estimated Enrollment: 69
Study Start Date: January 2014
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin D
Vitamin D3, 50,000 IU, weekly
Dietary Supplement: Vitamin D
Capsule given by mouth once a week
Other Name: Vitamin D3 50,000 IU
Placebo Comparator: Placebo
Placebo comparator, weekly
Other: Placebo
One capsule given by mouth weekly
Other Name: Capsule placebo


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01971801

Contact: Alayne D Markland, DO 205-975-3503
Contact: Laurie Slay 205-975-3503

United States, Alabama
UAB Continence Clinic at The Kirklin Clinic Recruiting
Birmingham, Alabama, United States, 35294
Contact: Laurie Slay    205-975-3503   
Contact: Patricia Goode, MD    205-558-7067   
Principal Investigator: Alayne D Markland, DO         
Sponsors and Collaborators
University of Alabama at Birmingham
Principal Investigator: Alayne D Markland, DO University of Alabama at Birmingham
  More Information

Responsible Party: University of Alabama at Birmingham Identifier: NCT01971801     History of Changes
Other Study ID Numbers: VAMC11 
Study First Received: October 17, 2013
Last Updated: August 26, 2016

Keywords provided by University of Alabama at Birmingham:
urinary incontinence
bowel incontinence
vitamin D
overactive bladder
lower urinary tract symptoms
quality of life

Additional relevant MeSH terms:
Urination Disorders
Urinary Incontinence
Vitamin D Deficiency
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Deficiency Diseases
Nutrition Disorders
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on February 20, 2017