Skip to main content
OpenTrials
Completed

NCT Number: NCT01971801

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Urinary Incontinence Avitaminosis Deficiency Diseases Digestive System Diseases Fecal Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Intestinal Diseases Lower Urinary Tract Symptoms Male Urogenital Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations Vitamin D Deficiency

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UAB Continence Clinic at The Kirklin Clinic

Birmingham, Alabama, 35294, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Vitamin D3 50,000 IU

Dietary Supplement

Capsule given by mouth once a week

Placebo

Other

One capsule given by mouth weekly

Other names: Capsule placebo

Primary outcomes

  1. 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 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.

Secondary outcomes

  1. Change in UI symptoms (ICIQ-UI and ICIQ-OAB scores)

    Time frame: baseline to 12 weeks

    Questionnaires

  2. Change in quality of life (Overactive Bladder Questionnaire)

    Time frame: baseline to 12 weeks

    Questionnaires

  3. Change in satisfaction with treatment (Perceptions and Satisfaction Questionnaire)

    Time frame: baseline to 12 weeks

    Questionnaire

  4. Change in safety of the treatments (side effects and unanticipated events)

    Time frame: baseline to 12 weeks

    Checklist

  5. Mechanisms of improvement based on measure of mobility

    Time frame: baseline to 12 weeks

    Physical examination

  6. Bowel incontinence symptoms

    Time frame: baseline to 12 weeks

    Questionnaire

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 29, 2013
Registry last updated
Mar 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.