Vitamin D Supplementation in Older Adults With Urinary Incontinence
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Overactive Bladder, Gastrointestinal, Urology |
| Therapuetic Areas: | Gastroenterology, Nephrology / Urology, Other |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 4/17/2018 |
| Start Date: | January 2014 |
| End Date: | November 2017 |
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.
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.
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).
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