Vitamin D Supplementation in Older Adults With Urinary Incontinence

This study has been completed.
Information provided by (Responsible Party):
University of Alabama at Birmingham Identifier:
First received: October 17, 2013
Last updated: March 23, 2016
Last verified: March 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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]

  • Change in quality of life (Overactive Bladder Questionnaire) [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]

  • Change in satisfaction with treatment (Perceptions and Satisfaction Questionnaire) [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]

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

  • Mechanisms of improvement based on measure of mobility [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]
    Physical examination

  • Bowel incontinence symptoms [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: January 2014
Study Completion Date: January 2016
Primary Completion Date: January 2016 (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
Genders 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).

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Please refer to this study by its identifier: NCT01971801

United States, Alabama
UAB Continence Clinic at The Kirklin Clinic
Birmingham, Alabama, United States, 35294
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: March 23, 2016
Health Authority: United States: Food and Drug Administration

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:
Urinary Incontinence
Vitamin D Deficiency
Deficiency Diseases
Lower Urinary Tract Symptoms
Nutrition Disorders
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations
Vitamin D
Bone Density Conservation Agents
Growth Substances
Physiological Effects of Drugs processed this record on May 26, 2016