An interventional study of Vitamin D3 50,000 IU and Placebo in Urinary Incontinence and Vitamin D Deficiency, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to female participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2018-03-09.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment
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.
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's enrollment of 243 is above the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
(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).
Vitamin D3, 50,000 IU, weekly
Dietary Supplement: Vitamin D3 50,000 IU
Placebo comparator, weekly
Other: Placebo
Capsule given by mouth once a week
One capsule given by mouth weekly
Also known as: Capsule placebo
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.
Time frame: baseline to 12 weeks
Change in UI symptoms (ICIQ-UI and ICIQ-OAB scores)
Questionnaires
Time frame: baseline to 12 weeks
Change in quality of life (Overactive Bladder Questionnaire)
Questionnaires
Time frame: baseline to 12 weeks
Change in satisfaction with treatment (Perceptions and Satisfaction Questionnaire)
Questionnaire
Time frame: baseline to 12 weeks
Change in safety of the treatments (side effects and unanticipated events)
Checklist
Time frame: baseline to 12 weeks
Mechanisms of improvement based on measure of mobility
Physical examination
Time frame: baseline to 12 weeks
Bowel incontinence symptoms
Questionnaire
Time frame: baseline to 12 weeks
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham