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Vitamin D Supplementation in Older Adults With Urinary Incontinence

Primary Purpose

Urinary Incontinence, Vitamin D Deficiency

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Vitamin D3 50,000 IU

Placebo

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring urinary incontinence, bowel incontinence, vitamin D, overactive bladder, lower urinary tract symptoms, quality of life

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

UAB Continence Clinic at The Kirklin Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Vitamin D

Placebo

Arm Description

Vitamin D3, 50,000 IU, weekly

Placebo comparator, weekly

Outcomes

Primary Outcome Measures

Change in the number of incontinent episodes on a 7-day bladder diary

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 Outcome Measures

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

Questionnaires

Change in quality of life (Overactive Bladder Questionnaire)

Questionnaires

Change in satisfaction with treatment (Perceptions and Satisfaction Questionnaire)

Questionnaire

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

Checklist

Mechanisms of improvement based on measure of mobility

Physical examination

Bowel incontinence symptoms

Questionnaire

Full Information

NCT ID

NCT01971801

First Posted

October 17, 2013

Last Updated

March 7, 2018

Sponsor

University of Alabama at Birmingham

1. Study Identification

Unique Protocol Identification Number

NCT01971801

Brief Title

Vitamin D Supplementation in Older Adults With Urinary Incontinence

Official Title

Vitamin D Supplementation in Older Adults With Urinary Incontinence

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

January 2014 (undefined)

Primary Completion Date

August 2017 (Actual)

Study Completion Date

November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Alabama at Birmingham

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Incontinence, Vitamin D Deficiency

Keywords

urinary incontinence, bowel incontinence, vitamin D, overactive bladder, lower urinary tract symptoms, quality of life

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

243 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vitamin D

Arm Type

Active Comparator

Arm Description

Vitamin D3, 50,000 IU, weekly

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo comparator, weekly

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D3 50,000 IU

Intervention Description

Capsule given by mouth once a week

Intervention Type

Other

Intervention Name(s)

Placebo

Other Intervention Name(s)

Capsule placebo

Intervention Description

One capsule given by mouth weekly

Primary Outcome Measure Information:

Title

Change in the number of incontinent episodes on a 7-day bladder diary

Description

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.

Time Frame

baseline to 12 weeks

Secondary Outcome Measure Information:

Title

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

Description

Questionnaires

Time Frame

baseline to 12 weeks

Title

Change in quality of life (Overactive Bladder Questionnaire)

Description

Questionnaires

Time Frame

baseline to 12 weeks

Title

Change in satisfaction with treatment (Perceptions and Satisfaction Questionnaire)

Description

Questionnaire

Time Frame

baseline to 12 weeks

Title

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

Description

Checklist

Time Frame

baseline to 12 weeks

Title

Mechanisms of improvement based on measure of mobility

Description

Physical examination

Time Frame

baseline to 12 weeks

Title

Bowel incontinence symptoms

Description

Questionnaire

Time Frame

baseline to 12 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alayne D Markland, DO

Organizational Affiliation

University of Alabama at Birmingham

Official's Role

Principal Investigator

Facility Information:

Facility Name

UAB Continence Clinic at The Kirklin Clinic

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

30578542

Citation

Markland AD, Tangpricha V, Mark Beasley T, Vaughan CP, Richter HE, Burgio KL, Goode PS. Comparing Vitamin D Supplementation Versus Placebo for Urgency Urinary Incontinence: A Pilot Study. J Am Geriatr Soc. 2019 Mar;67(3):570-575. doi: 10.1111/jgs.15711. Epub 2018 Dec 21.

Results Reference

derived

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Vitamin D Supplementation in Older Adults With Urinary Incontinence

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