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Vitamin D Supplementation in Older Adults With Urinary Incontinence

This study is currently recruiting participants.
Verified March 2017 by Alayne D. Markland, DO, MSc, University of Alabama at Birmingham
Sponsor:
ClinicalTrials.gov Identifier:
NCT01971801
First Posted: October 29, 2013
Last Update Posted: March 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Alayne D. Markland, DO, MSc, University of Alabama at Birmingham
  Purpose
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
Urinary Incontinence Vitamin D Deficiency Dietary Supplement: Vitamin D3 50,000 IU Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Alayne D. Markland, DO, MSc, 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 ]
    Questionnaires

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

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

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

  • 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 ]
    Questionnaire


Estimated Enrollment: 69
Study Start Date: January 2014
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Capsule placebo

  Eligibility

Information from the National Library of Medicine

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01971801


Contacts
Contact: Alayne D Markland, DO 205-975-3503 amarkland@uabmc.edu
Contact: Laurie Slay 205-975-3503 laurieslay@uabmc.edu

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

Responsible Party: Alayne D. Markland, DO, MSc, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01971801     History of Changes
Other Study ID Numbers: VAMC11
First Submitted: October 17, 2013
First Posted: October 29, 2013
Last Update Posted: March 13, 2017
Last Verified: March 2017

Keywords provided by Alayne D. Markland, DO, MSc, 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
Enuresis
Vitamin D Deficiency
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents