Vitamin D Supplementation in Older Adults With Urinary Incontinence

NCT01971801 | Completed DMC

• 1 other identifier: VAMC11
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence; Vitamin D Deficiency

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline to 12 weeks

Secondary Outcomes (6)

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

  baseline to 12 weeks

• Change in quality of life (Overactive Bladder Questionnaire)

  baseline to 12 weeks

• Change in satisfaction with treatment (Perceptions and Satisfaction Questionnaire)

  baseline to 12 weeks

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

  baseline to 12 weeks

• Mechanisms of improvement based on measure of mobility

  baseline to 12 weeks

Study Arms (2)

Vitamin D

ACTIVE COMPARATOR

Vitamin D3, 50,000 IU, weekly

Dietary Supplement: Vitamin D3 50,000 IU

Placebo

PLACEBO COMPARATOR

Placebo comparator, weekly

Other: Placebo

Interventions

Vitamin D3 50,000 IU DIETARY_SUPPLEMENT

Capsule given by mouth once a week

Vitamin D

Placebo OTHER

One capsule given by mouth weekly

Also known as: Capsule placebo

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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).

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB Continence Clinic at The Kirklin Clinic

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• 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.

  PMID: 30578542 DERIVED

MeSH Terms

Conditions

Urinary Incontinence; Vitamin D Deficiency; Fecal Incontinence; Urinary Bladder, Overactive; Lower Urinary Tract Symptoms

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Urinary Bladder Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Alayne D Markland, DO

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 17, 2013
• First Posted: October 29, 2013
• Study Start: January 1, 2014
• Primary Completion: August 1, 2017
• Study Completion: November 1, 2017
• Last Updated: March 9, 2018

Record last verified: 2018-03

Locations

US (1)