EnuresisNCT06508333
Efficacy and Safety of Vitamin D Supplementation Combined With Alarm Therapy in Treating Nocturnal Enuresis
A study testing alarm therapy and Vitamin D3 in people with Enuresis, run by Xing Liu at 1 site in China.
Trial summary
This prospective, randomized, two-arm, parallel-design controlled clinical trial aims to determine whether high-dose vitamin D supplementation combined with alarm therapy improves outcomes in children with primary monosymptomatic nocturnal enuresis compared to alarm therapy alone. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Enuresis
- What is being tested?
- alarm therapy and Vitamin D3
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 31 May 2025
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children aged 5-18 years diagnosed with PMNE-defined as intermittent urinary incontinence during sleep in a children who are never dry for more than 6 months and have no other lower urinary tract symptoms-according to the latest International Children's Continence Society guidelines, presenting at outpatient urology clinics.
- Serum vitamin D level below 30 ng/mL.
- Written informed consent obtained from each participant and their guardian.
- Adequate psychological and cognitive function, no communication barriers, and ability to accurately report symptoms and potential adverse reactions during treatment.
Who cannot join
- Urological malformations or serious urological disease, such as hypospadias, cryptorchidism, posterior urethral valves, vesicoureteral reflux, neurogenic bladder, urinary tumors, urinary stones, or bladder/urethral injuries.
- Neurological disorders, including epilepsy, spinal cord injury or dysplasia, spinal embolism syndrome, multiple sclerosis, autism spectrum disorder, or attention-deficit/hyperactivity disorder.
- Endocrine diseases, such as diabetes mellitus or hyperthyroidism.
- Severe systemic disease, including significant cardiac disease, renal or hepatic insufficiency, pulmonary disease, bone deformities, gastrointestinal disorders, or inherited metabolic disorders.
- Conditions predisposing to sleep apnea, such as adenoid or tonsillar hypertrophy, deviated nasal septum, craniofacial abnormalities, or central sleep apnea.
- History of gastrointestinal or urological surgery.
Show all 12Show fewer
- Use of anticonvulsant, antiepileptic, corticosteroid, or anti-tuberculosis medications.
- History of hypercalcemia, hyperphosphatemia, or renal rickets.
- Unexplained hematuria or urinary tract infection within the past year.
- Allergy to vitamin D formulations.
- Concurrent participation in other clinical studies.
- Unwillingness to participate or poor anticipated follow-up compliance.
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000
About this study
Official title: Efficacy and Safety of Vitamin D Supplementation Combined With Alarm Therapy in Treating Nocturnal Enuresis: A Prospective, Randomized Controlled Trial
This prospective, randomized, two-arm, parallel-design controlled clinical trial aims to determine whether high-dose vitamin D supplementation combined with alarm therapy improves outcomes in children with primary monosymptomatic nocturnal enuresis compared to alarm therapy alone.
Read the detailed description
Nocturnal enuresis (NE) is characterized by recurrent involuntary urination during sleep in children aged 5 years and older, persisting for over three months with at least two episodes per week. This condition, resulting from the child's inability to awaken from sleep, exhibits a prevalence rate ranging from 4.8% to 15.2%, which notably declines with age. Moreover, NE significantly impacts the psychological well-being and overall quality of life of affected individuals. The primary treatments for NE include desmopressin acetate (DDAVP) and behavioral interventions (BI). While these modalities offer therapeutic benefits, their implementation is often prolonged and fraught with challenges, including adverse drug reactions and a high rate of symptom recurrence after treatment discontinuation. These factors complicate adherence for both patients and their families.
Patients with NE are more likely to suffer from vitamin D deficiency. This study aims to determine the effect of vitamin D supplementation as an adjunctive therapy to alarm therapy in the treatment of primary monosymptomatic nocturnal enuresis(PMNE). Eligible patients aged 5-18 years with a diagnosis of NE will be randomly assigned to receive either high-dose vitamin D supplementation combined with alarm therapy or alarm therapy alone. Serum levels of 25(OH)D will be measured at baseline. Symptom severity will be assessed at baseline and follow-up, along with other sociodemographic data. This study will provide more information on the role of vitamin D supplementation in managing PMNE.
- Conditions
- Enuresis
- Being tested
- alarm therapy, Vitamin D3
- Medical subject headings
- Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alarm therapyBehavioural
These patients will receive alarm therapy for 8 weeks.
Vitamin D3Drug
These patients will receive high-dose vitamin D supplementation (more than 2000IU daily) (combined with alarm therapy) for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Alarm therapy | Active comparator | These patients will receive alarm therapy for 8 weeks Receives: Behavioral: alarm therapy |
| Alarm therapy combined with short-term high dose exogenous vitamin D supplementation | Experimental | These patients will receive high-dose vitamin D supplementation (more than 2000IU daily) and alarm therapy for 8 weeks Receives: Behavioral: alarm therapy; Drug: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response after interventions
Response rate: defined as a ≥50% reduction in the number of wet nights per week
Measured: 8 weeks
Complete response after interventions
The rate of complete response was defined as a 100% reduction in wet nights per week.
Measured: 8 weeks
Secondary outcomes (8)
Change in enuresis frequency
Change in enuresis frequency from baseline to follow-up
Measured: 8 weeks
Change in quality of life score
The quality of life was assessed using a scale ranging from 0 to 3, where a score of 0 indicated no impact on family, social, or academic life, a score of 1 indicated occasional impact, a score of 2 indicated significant impact, and a score of 3 indicated severe impact on family, social, or academic life.
Measured: 8 week
Change in vitamin D level
Change in vitamin D level from baseline to follow-up
Measured: 8 week
Change in serum levels of calcium
Change in serum levels of calcium from baseline to follow-up
Measured: 8 weeks
Global perception of improvement
Global perception of improvement (much better; better; about the same; worse)
Measured: 8 week
Wish to receive another form of treatment?
Wish to receive another form of treatment? (YES; No)
Measured: 8 week
Treatment adherence
The extent to which a patient adheres to their medication schedule, including both timing and dosage, or follows the prescribed treatment regimen
Measured: 8 week
Incidence of side effects
Type and frequency of side effects during treatment
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start1 Dec 2024
- Primary completion31 Mar 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for EnuresisStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xing Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xing Liu, Children's Hospital of Chongqing Medical University
- Investigators
- Xing Liu, Doctor, Study director, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508333
- Sponsor's protocol ID
- 2024424
- Status last verified
- Feb 2026
- First submitted
- 14 Jul 2024
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Apart from the participant's personal information.
Publications
Wen JG, Wang QW, Chen Y, Wen JJ, Liu K. An epidemiological study of primary nocturnal enuresis in Chinese children and adolescents. Eur Urol. 2006 Jun;49(6):1107-13. doi: 10.1016/j.eururo.2005.11.011. Epub 2005 Dec 27.
PubMed 16406243Robson WL. Clinical practice. Evaluation and management of enuresis. N Engl J Med. 2009 Apr 2;360(14):1429-36. doi: 10.1056/NEJMcp0808009. No abstract available.
PubMed 19339722Hara T, Ohtomo Y, Endo A, Niijima S, Yasui M, Shimizu T. Evaluation of Urinary Aquaporin 2 and Plasma Copeptin as Biomarkers of Effectiveness of Desmopressin Acetate for the Treatment of Monosymptomatic Nocturnal Enuresis. J Urol. 2017 Oct;198(4):921-927. doi: 10.1016/j.juro.2017.04.088. Epub 2017 Apr 28.
PubMed 28457803Jorgensen CS, Horsdal HT, Rajagopal VM, Grove J, Als TD, Kamperis K, Nyegaard M, Walters GB, Eethvarethsson VO, Stefansson H, Nordentoft M, Hougaard DM, Werge T, Mors O, Mortensen PB, Agerbo E, Rittig S, Stefansson K, Borglum AD, Demontis D, Christensen JH. Identification of genetic loci associated with nocturnal enuresis: a genome-wide association study. Lancet Child Adolesc Health. 2021 Mar;5(3):201-209. doi: 10.1016/S2352-4642(20)30350-3. Epub 2021 Jan 15.
PubMed 33453761Tsuji S, Suruda C, Kimata T, Kino J, Yamanouchi S, Kaneko K. The Effect of Family Assistance to Wake Children with Monosymptomatic Enuresis in Alarm Therapy: A Pilot Study. J Urol. 2018 Apr;199(4):1056-1060. doi: 10.1016/j.juro.2017.11.072. Epub 2017 Nov 23.
PubMed 29175540Yeung CK, Sihoe JD, Sit FK, Diao M, Yew SY. Urodynamic findings in adults with primary nocturnal enuresis. J Urol. 2004 Jun;171(6 Pt 2):2595-8. doi: 10.1097/01.ju.0000112790.72612.0a.
PubMed 15118427Ye Z, Luo X, Chen H, Zhang Q, Li C, Zhang Z, Wu S, Zhang D, Hua Y, Wei G, Liu X. Efficacy and Safety of High-Dose Vitamin D Supplementation Combined With an Enuresis Alarm vs Alarm Alone in Children With Primary Monosymptomatic Nocturnal Enuresis: A Randomized Clinical Trial. J Urol. 2026 Aug;216(2):182-193. doi: 10.1097/JU.0000000000005071. Epub 2026 Apr 29.
PubMed 42054624
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Vitamin D Supplementation Combined With Alarm Therapy in Treating Nocturnal Enuresis: A Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06508333
- Acronym / sponsor ID
- 2024424
- Conditions
- Enuresis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Xing LiuUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 18 Jul 2024 (actual)
- 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.
This prospective, randomized, two-arm, parallel-design controlled clinical trial aims to determine whether high-dose vitamin D supplementation combined with alarm therapy improves outcomes in children with primary monosymptomatic nocturnal enuresis compared to alarm therapy alone.
Detailed description
Nocturnal enuresis (NE) is characterized by recurrent involuntary urination during sleep in children aged 5 years and older, persisting for over three months with at least two episodes per week. This condition, resulting from the child's inability to awaken from sleep, exhibits a prevalence rate ranging from 4.8% to 15.2%, which notably declines with age. Moreover, NE significantly impacts the psychological well-being and overall quality of life of affected individuals. The primary treatments for NE include desmopressin acetate (DDAVP) and behavioral interventions (BI). While these modalities offer therapeutic benefits, their implementation is often prolonged and fraught with challenges, including adverse drug reactions and a high rate of symptom recurrence after treatment discontinuation. These factors complicate adherence for both patients and their families.
Patients with NE are more likely to suffer from vitamin D deficiency. This study aims to determine the effect of vitamin D supplementation as an adjunctive therapy to alarm therapy in the treatment of primary monosymptomatic nocturnal enuresis(PMNE). Eligible patients aged 5-18 years with a diagnosis of NE will be randomly assigned to receive either high-dose vitamin D supplementation combined with alarm therapy or alarm therapy alone. Serum levels of 25(OH)D will be measured at baseline. Symptom severity will be assessed at baseline and follow-up, along with other sociodemographic data. This study will provide more information on the role of vitamin D supplementation in managing PMNE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alarm therapy | Active comparator | Behavioral: alarm therapyThese patients will receive alarm therapy for 8 weeks |
| Alarm therapy combined with short-term high dose exogenous vitamin D supplementation | Experimental | Behavioral: alarm therapy, Drug: Vitamin D3These patients will receive high-dose vitamin D supplementation (more than 2000IU daily) and alarm therapy for 8 weeks |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Children aged 5-18 years diagnosed with PMNE-defined as intermittent urinary incontinence during sleep in a children who are never dry for more than 6 months and have no other lower urinary tract symptoms-according to the latest International Children's Continence Society guidelines, presenting at outpatient urology clinics.
- Serum vitamin D level below 30 ng/mL.
- Written informed consent obtained from each participant and their guardian.
- Adequate psychological and cognitive function, no communication barriers, and ability to accurately report symptoms and potential adverse reactions during treatment.
Key exclusion criteria (12 listed)
- Urological malformations or serious urological disease, such as hypospadias, cryptorchidism, posterior urethral valves, vesicoureteral reflux, neurogenic bladder, urinary tumors, urinary stones, or bladder/urethral injuries.
- Neurological disorders, including epilepsy, spinal cord injury or dysplasia, spinal embolism syndrome, multiple sclerosis, autism spectrum disorder, or attention-deficit/hyperactivity disorder.
- Endocrine diseases, such as diabetes mellitus or hyperthyroidism.
- Severe systemic disease, including significant cardiac disease, renal or hepatic insufficiency, pulmonary disease, bone deformities, gastrointestinal disorders, or inherited metabolic disorders.
- Conditions predisposing to sleep apnea, such as adenoid or tonsillar hypertrophy, deviated nasal septum, craniofacial abnormalities, or central sleep apnea.
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 |
|---|---|---|
| alarm therapyThese patients will receive alarm therapy for 8 weeks. | Behavioural | Alarm therapy, Alarm therapy combined with short-term high dose exogenous vitamin D supplementation |
| Vitamin D3These patients will receive high-dose vitamin D supplementation (more than 2000IU daily) (combined with alarm therapy) for 8 weeks. | Drug | Alarm therapy combined with short-term high dose exogenous vitamin D supplementation |
Primary outcome
Response after interventions
Time frame: 8 weeks
Response rate: defined as a ≥50% reduction in the number of wet nights per week
Complete response after interventions
Time frame: 8 weeks
The rate of complete response was defined as a 100% reduction in wet nights per week.
8 secondary outcomes
Change in enuresis frequency
Time frame: 8 weeks
Change in quality of life score
Time frame: 8 week
Change in vitamin D level
Time frame: 8 week
Change in serum levels of calcium
Time frame: 8 weeks
Global perception of improvement
Time frame: 8 week
Wish to receive another form of treatment?
Time frame: 8 week
Treatment adherence
Time frame: 8 week
Incidence of side effects
Time frame: 8 week
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 23 Feb 2026.
- Background: PubMed 16406243Wen JG, Wang QW, Chen Y, Wen JJ, Liu K. An epidemiological study of primary nocturnal enuresis in Chinese children and adolescents. Eur Urol. 2006 Jun;49(6):1107-13. doi: 10.1016/j.eururo.2005.11.011. Epub 2005 Dec 27.
- Background: PubMed 19339722Robson WL. Clinical practice. Evaluation and management of enuresis. N Engl J Med. 2009 Apr 2;360(14):1429-36. doi: 10.1056/NEJMcp0808009. No abstract available.
- Background: PubMed 28457803Hara T, Ohtomo Y, Endo A, Niijima S, Yasui M, Shimizu T. Evaluation of Urinary Aquaporin 2 and Plasma Copeptin as Biomarkers of Effectiveness of Desmopressin Acetate for the Treatment of Monosymptomatic Nocturnal Enuresis. J Urol. 2017 Oct;198(4):921-927. doi: 10.1016/j.juro.2017.04.088. Epub 2017 Apr 28.
- Background: PubMed 33453761Jorgensen CS, Horsdal HT, Rajagopal VM, Grove J, Als TD, Kamperis K, Nyegaard M, Walters GB, Eethvarethsson VO, Stefansson H, Nordentoft M, Hougaard DM, Werge T, Mors O, Mortensen PB, Agerbo E, Rittig S, Stefansson K, Borglum AD, Demontis D, Christensen JH. Identification of genetic loci associated with nocturnal enuresis: a genome-wide association study. Lancet Child Adolesc Health. 2021 Mar;5(3):201-209. doi: 10.1016/S2352-4642(20)30350-3. Epub 2021 Jan 15.
- Background: PubMed 29175540Tsuji S, Suruda C, Kimata T, Kino J, Yamanouchi S, Kaneko K. The Effect of Family Assistance to Wake Children with Monosymptomatic Enuresis in Alarm Therapy: A Pilot Study. J Urol. 2018 Apr;199(4):1056-1060. doi: 10.1016/j.juro.2017.11.072. Epub 2017 Nov 23.
- Background: PubMed 15118427Yeung CK, Sihoe JD, Sit FK, Diao M, Yew SY. Urodynamic findings in adults with primary nocturnal enuresis. J Urol. 2004 Jun;171(6 Pt 2):2595-8. doi: 10.1097/01.ju.0000112790.72612.0a.
- Derived from this study: PubMed 42054624Ye Z, Luo X, Chen H, Zhang Q, Li C, Zhang Z, Wu S, Zhang D, Hua Y, Wei G, Liu X. Efficacy and Safety of High-Dose Vitamin D Supplementation Combined With an Enuresis Alarm vs Alarm Alone in Children With Primary Monosymptomatic Nocturnal Enuresis: A Randomized Clinical Trial. J Urol. 2026 Aug;216(2):182-193. doi: 10.1097/JU.0000000000005071. Epub 2026 Apr 29.
- Individual participant dataSharing planned: Yes. Apart from the participant's personal information.
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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.
Xing Liu, Doctor study director
Children's Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing alarm therapy and Vitamin D3 in people with Enuresis, run by Xing Liu at 1 site in China.
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 4 inclusion and 12 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 23 Feb 2026. 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 China. 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. 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?
Response after interventions (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 NCT06508333, which also lists 7 linked publications.
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 23 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.