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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 2014 by University of Alabama at Birmingham
Sponsor:
Information provided by (Responsible Party):
Alayne D. Markland, DO, MSc, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01971801
First received: October 17, 2013
Last updated: August 11, 2014
Last verified: August 2014
  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 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 ]
    Questionnaires

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

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

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

  • 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 ]
    Questionnaire


Estimated Enrollment: 100
Study Start Date: January 2014
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (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

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

(1) Post-menopausal women (age ≥55 years of age0; (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 <20 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.

  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 ClinicalTrials.gov identifier: NCT01971801

Contacts
Contact: Alayne D Markland, DO 205-975-3503 amarkland@uabmc.edu
Contact: J. Lynn Shanks 205-975-3503 jlshanks@uabmc.edu

Locations
United States, Alabama
UAB Continence Clinic at The Kirklin Clinic Recruiting
Birmingham, Alabama, United States, 35294
Contact: J. Lynn Shanks    205-975-3503    jlshanks@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

No publications provided

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
Study First Received: October 17, 2013
Last Updated: August 11, 2014
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
Avitaminosis
Deficiency Diseases
Lower Urinary Tract Symptoms
Malnutrition
Nutrition Disorders
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014