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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D | Active Comparator | Vitamin D3, 50,000 IU, weekly |
|
| Placebo | Placebo Comparator | Placebo comparator, weekly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 50,000 IU | Dietary Supplement | Capsule given by mouth once a week |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in UI symptoms (ICIQ-UI and ICIQ-OAB scores) | Questionnaires | baseline to 12 weeks |
| Change in quality of life (Overactive Bladder Questionnaire) | Questionnaires |
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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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| Name | Affiliation | Role |
|---|---|---|
| Alayne D Markland, DO | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Continence Clinic at The Kirklin Clinic | Birmingham | Alabama | 35294 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30578542 | Derived | 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. |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014808 | Vitamin D Deficiency |
| D005242 | Fecal Incontinence |
| D053201 | Urinary Bladder, Overactive |
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Placebo |
| Other |
One capsule given by mouth weekly |
|
|
| baseline to 12 weeks |
| Change in satisfaction with treatment (Perceptions and Satisfaction Questionnaire) | Questionnaire | baseline to 12 weeks |
| Change in safety of the treatments (side effects and unanticipated events) | Checklist | baseline to 12 weeks |
| Mechanisms of improvement based on measure of mobility | Physical examination | baseline to 12 weeks |
| Bowel incontinence symptoms | Questionnaire | baseline to 12 weeks |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D001745 | Urinary Bladder Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |