Effect of Vitamin D Supplementation on Urinary Incontinence in Older Women: Ancillary Findings from a Randomized Trial

Markland A1, Vaughan C2, Huang A3, Tangpricha V2, Kim E4, Bubes V4, Lee I4, Cook N4, Buring J4, Grodstein F5, Manson J4

Research Type

Clinical

Abstract Category

Geriatrics / Gerontology

Abstract 426
Geriatrics and Special Population
Scientific Podium Short Oral Session 27
On-Demand
Clinical Trial Gerontology Prevention Incontinence Outcomes Research Methods
1. UAB, 2. Emory, 3. UCSF, 4. BWH/Harvard, 5. Rush
Presenter
A

Alayne Markland

Links

Abstract

Hypothesis / aims of study
Despite observational research indicating that vitamin D insufficiency is associated with increased prevalence and incidence of urinary incontinence (UI), almost no randomized trial data are available to indicate whether supplementation with vitamin D reduces UI [1-3].  Given the unique opportunity to test vitamin D supplementation as a possible preventive treatment to reduce UI among older women [3], we proposed an ancillary analysis of women enrolled in a nationwide vitamin D and omega-3 prevention trial for cancer and cardiovascular disease, the VITamin D and omegA-3 TriaL (VITAL) clinical trial. Our objectives were to evaluate the effects of vitamin D supplementation on UI incidence and prevalence at follow-up at 2 and 5 years after randomization (the years in which UI items were included in participant questionnaires). We hypothesized that older women assigned to vitamin D, especially those with low serum 25-hydroxyvitamin D (25OHD) levels at baseline, will have lower incidence and progression rates of UI than women assigned to placebos.
Study design, materials and methods
We performed a pre-specified ancillary study to VITAL, a 2 x 2 factorial randomized trial conducted among 25,871 participants (including 13,085 women) recruited between November 2011 and March 2014 from all 50 US states. Follow-up was completed in January 2018. Randomized treatments included: 1) vitamin D3 (cholecalciferol) at a dose of 2000 IU/day, and 2) placebo. Validated UI questions were assessed in year 2 and repeated in year 5 at the trial close. The pre-specified outcomes were the prevalence of UI at year 2 and at year 5, along with UI incidence and UI progression from year 2 to year 5, with subgroup analysis for women with low baseline serum levels of 25OHD (<30 ng/mL). Among the 13,085 women randomized, we had UI data from 11,646 women at year 2 and 10,527 at year 5. For the primary analyses, women were analyzed according to their randomization to vitamin D supplementation or placebo using the intention-to-treat principle, along with similar analyses among women with 25OHD biosamples at baseline (n=2,819).
Results
No sociodemographic differences were seen between all women with UI data randomized to vitamin D versus placebo or between women with low serum 25OHD randomized to vitamin D versus placebo at year 2 (mean age = 70.1 years, 29% racial/ethnic minority).  At year 2, 64% reported UI, and this increased to 71% at year 5. Supplementation with vitamin D compared to placebo was not associated with lower odds of prevalent UI at year 2 or at year 5 (Table). In women with low serum 25OHD, no differences were found in prevalent UI at year 2 or at year 5 (Table). No differences were found for progression of UI or incidence of UI at year 5, including among women with low serum 25OHD (Table).  For all women and women with low serum 25OHD, UI type (urge, stress, mixed, or other) did not differ between randomization groups at year 2 or at year 5 (data not shown).
Interpretation of results
Vitamin D supplementation of 2,000 IU daily in older women was not associated with decreases in UI prevalence after two years or five years, or with decreased progression or incidence of UI, even among women with low 25OHD prior to randomization.
Concluding message
This study provides novel clinical trial evidence that 2000 IU of vitamin D supplementation compared to placebo does not improve UI in older women after 2 to 5 years of treatment.
Figure 1
References
  1. Badalian SS, Rosenbaum PF. Vitamin D and pelvic floor disorders in women: results from the National Health and Nutrition Examination Survey. Obstet Gynecol 2010.
  2. Vaughan CP, Tangpricha V, Motahar-Ford N, Goode PS, Burgio KL, Allman RM, Daigle SG, Redden DT, Markland AD. Vitamin D and incident urinary incontinence in older adults. Eur J Clin Nutr 2016.
  3. 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 2018.
Disclosures
Funding Ancillary study supported by the National Institute of Diabetes and Digestive, and Kidney Diseases/National Institutes of Health (R01DK115473). Primary study Supported by grants (U01 CA138962 and R01 CA138962) from the National Cancer Institute, the National Heart, Lung, and Blood Institute, the Office of Dietary Supplements, the National Institute of Neurological Disorders and Stroke, and the National Center for Complementary and Integrative Health. Clinical Trial Yes Registration Number clinicaltrials.gov NCT01169259 RCT Yes Subjects Human Ethics Committee the Institutional Review Board of Brigham and Women's Hospital, Harvard Medical School Helsinki Yes Informed Consent Yes
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