Urinary IncontinenceNCT01971801
Vitamin D Supplementation in Older Adults With Urinary Incontinence
A study testing Vitamin D3 50,000 IU in people with Urinary Incontinence and Vitamin D Deficiency, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Vitamin D Deficiency
- What is being tested?
- Vitamin D3 50,000 IU
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 243 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
UAB Continence Clinic at The Kirklin Clinic
Birmingham, Alabama, 35294
About this study
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
- Being tested
- Vitamin D3 50,000 IU, Placebo
- Keywords
- urinary incontinence, bowel incontinence, vitamin D, overactive bladder, lower urinary tract symptoms, quality of life
- Medical subject headings
- Urinary Incontinence, Vitamin D Deficiency, Fecal Incontinence, Urinary Bladder, Overactive, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 50,000 IUDietary supplement
Capsule given by mouth once a week
PlaceboOther
Also called Capsule placebo
One capsule given by mouth weekly
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Active comparator | Vitamin D3, 50,000 IU, weekly Receives: Dietary Supplement: Vitamin D3 50,000 IU |
| Placebo | Placebo comparator | Placebo comparator, weekly Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline to 12 weeks
Secondary outcomes (6)
Change in UI symptoms (ICIQ-UI and ICIQ-OAB scores)
Questionnaires
Measured: baseline to 12 weeks
Change in quality of life (Overactive Bladder Questionnaire)
Questionnaires
Measured: baseline to 12 weeks
Change in satisfaction with treatment (Perceptions and Satisfaction Questionnaire)
Questionnaire
Measured: baseline to 12 weeks
Change in safety of the treatments (side effects and unanticipated events)
Checklist
Measured: baseline to 12 weeks
Mechanisms of improvement based on measure of mobility
Physical examination
Measured: baseline to 12 weeks
Bowel incontinence symptoms
Questionnaire
Measured: baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2013 (estimated)
- Study startJan 2014
- Primary completionAug 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alayne D. Markland, DO, MSc, University of Alabama at Birmingham
- Investigators
- Alayne D Markland, DO, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01971801
- Sponsor's protocol ID
- VAMC11
- Status last verified
- Mar 2018
- First submitted
- 17 Oct 2013
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30578542
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Supplementation in Older Adults With Urinary Incontinence
- ClinicalTrials.gov ID
- NCT01971801
- Acronym / sponsor ID
- VAMC11
- Conditions
- Urinary Incontinence, Vitamin D Deficiency
- Keywords
- urinary incontinence, bowel incontinence, vitamin D, overactive bladder, lower urinary tract symptoms, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Aug 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 29 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Active comparator | Dietary Supplement: Vitamin D3 50,000 IUVitamin D3, 50,000 IU, weekly |
| Placebo | Placebo comparator | Other: PlaceboPlacebo comparator, weekly |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3 50,000 IUCapsule given by mouth once a week | Dietary supplement | Vitamin D |
| PlaceboAlso: Capsule placeboOne capsule given by mouth weekly | Other | Placebo |
Primary outcome
Change in the number of incontinent episodes on a 7-day bladder diary
Time frame: baseline to 12 weeks
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.
6 secondary outcomes
Change in UI symptoms (ICIQ-UI and ICIQ-OAB scores)
Time frame: baseline to 12 weeks
Change in quality of life (Overactive Bladder Questionnaire)
Time frame: baseline to 12 weeks
Change in satisfaction with treatment (Perceptions and Satisfaction Questionnaire)
Time frame: baseline to 12 weeks
Change in safety of the treatments (side effects and unanticipated events)
Time frame: baseline to 12 weeks
Mechanisms of improvement based on measure of mobility
Time frame: baseline to 12 weeks
Bowel incontinence symptoms
Time frame: baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
- Derived from this study: PubMed 30578542Markland 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alayne D Markland, DO principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 50,000 IU in people with Urinary Incontinence and Vitamin D Deficiency, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the number of incontinent episodes on a 7-day bladder diary (time frame: baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01971801, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2018.