Nocturnal Enuresis in ChildrenNCT07876947
Potential Adjuvant Therapies for Children With Primary Nocturnal Enuresis
A study testing Dietary Salt Restriction and Omega Supplementation in people with Nocturnal Enuresis in Children and Primary Nocturnal Enuresis, run by Cairo University.
Trial summary
To examine the possible reduction in dietary salt intake on the outcomes of nocturnal enuresis Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Nocturnal Enuresis in Children, Primary Nocturnal Enuresis
- What is being tested?
- Dietary Salt Restriction and Omega Supplementation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 15 Jun 2027
- Phase
- Interventional
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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with Primary Nocturnal enuresis
- Age: above than 5 years
- Both sexes
- Children whose parents approve enrollment in the study
Who cannot join
- Secondary enuresis due to urinary tract infection or diabetes.
- Conditions affecting urinary function.
- Use of medications affecting sodium excretion, including diuretics or antidiuretic hormone (ADH).
- Children receiving omega supplementation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Salt Restriction and Omega as Potential Adjuvant Therapies for Children With Primary Nocturnal Enuresis, A Quasi-experimental Roll-over Clinical Trial
To examine the possible reduction in dietary salt intake on the outcomes of nocturnal enuresis
Read the detailed description
Primary nocturnal enuresis is the involuntary discharge of urine at night by children old enough to be expected to have bladder control. Children should not be labelled enuretic unless regular (more than twice per week) wetting persists beyond the age of five years. Primary nocturnal enuresis is more common in boys. Bedwetting is found in 10% to 15% of five-year-old children and 6% to 8% of eight-year-old children, and it declines to 1% to 2% by 15 years of age.
Although overactive bladder is commonly associated with enuresis, the clinical relationship between these two conditions remains to be clarified. It was previously reported that reducing the salt intake improved nocturia and nocturnal polyuria. Consequently, we have focused on the dietary modifications that may improve urinary disorders.
Omega-3 fatty acids may influence primary nocturnal enuresis by regulating prostaglandin E2, nitric oxide synthesis, and brain signaling [9]. There is evidence that omega-3 is a potent inhibitor of prostaglandin E2 synthesis; omega-3 fatty acids are a potent inhibitor of prostaglandin E2 synthesis. The present evidence suggests that the collecting duct is the site at which prostaglandins act to determine the corticomedullary solute gradient. leading to increased sodium excretion.
- Being tested
- Dietary Salt Restriction, Omega Supplementation
- Keywords
- Salt Restriction, Nocturnal Enuresis in children, Primary Nocturnal Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Salt RestrictionBehavioural
Participants with high dietary sodium intake will receive dietary counseling to reduce salt intake. The intervention includes a nutritional brochure, health education every four weeks, avoidance of hidden sources of sodium such as junk foods, and guidance on alternatives to salt such as lemon and vinegar.
Omega SupplementationDietary supplement
Participants who fail to restrict their sodium intake will receive omega supplementation at a dose of 1000 mg per day for 3 months. Outcomes will be assessed again after omega supplementation and compared with pre-intervention measurements.
| Study group | Role | What they receive |
|---|---|---|
| Salt Restriction | Experimental | Participants with primary nocturnal enuresis and high dietary sodium intake will receive dietary counseling to reduce sodium intake, including education on hidden sodium sources and salt alternatives. Receives: Behavioral: Dietary Salt Restriction |
| Omega Supplementation | Experimental | Participants who fail to restrict their sodium intake will receive omega supplementation at a dose of 1000 mg per day for 3 months. The study will reassess outcomes after omega supplementation and compare them with pre-intervention measurements. Receives: Dietary Supplement: Omega Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated 24-Hour Urinary Sodium Excretion
Estimated 24-hour urinary sodium excretion will be assessed using spot urine sodium and creatinine concentrations and a validated formula adjusted for age, body weight, and height.
Measured: At baseline and at the end of the salt-restriction intervention
Number of Bed-Wetting Episodes per Week
The number of nocturnal bed-wetting episodes per week will be assessed using a urinary chart completed for one week at baseline and at the end of the study.
Measured: At baseline and at the end of the salt-restriction intervention
Secondary outcomes (3)
Effect of Omega Supplementation on Estimated 24-Hour Urinary Sodium Excretion
Estimated 24-hour urinary sodium excretion will be assessed before and after omega supplementation using spot urinary sodium and creatinine concentrations and the specified estimation formula.
Measured: At the start of omega supplementation and after 3 months of omega supplementation
Effect of Omega Supplementation on Number of Bed-Wetting Episodes per Week
The number of nocturnal bed-wetting episodes per week will be assessed before and after omega supplementation using a one-week urinary chart.
Measured: At the start of omega supplementation and after 3 months of omega supplementation
Comparison of Salt Restriction and Omega Supplementation on Bed-Wetting Frequency and Urinary Sodium Excretion
The effects of salt restriction and omega supplementation will be compared regarding the frequency of bed-wetting and estimated 24-hour urinary sodium excretion.
Measured: At the end of the salt-restriction intervention and after 3 months of omega supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
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 Nocturnal Enuresis in ChildrenStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raoth Nabil, Cairo University
- Investigators
- Dalia Sayed Mosallam, Professor of pediatrics, Study chair, pediatrics and neonatology department , Cairo universityOmnia Rafaat Amin, Professor of pediatrics, Study director, pediatrics and neonatology department , Cairo universityHoda Atef Ibrahim, Lecturer of pediatrics, Study director, pediatrics and neonatology department , Cairo universityDina Mahmoud Nabil, Lecturer of clinical pathology, Study director, clinical pathology department , Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876947
- Sponsor's protocol ID
- Primary Nocturnal Enuresis
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Matsuo T, Miyata Y, Otsubo A, Mukae Y, Mitsunari K, Ohba K, Sakai H. Efficacy of salt reduction for managing overactive bladder symptoms: a prospective study in patients with excessive daily salt intake. Sci Rep. 2021 Feb 18;11(1):4046. doi: 10.1038/s41598-021-83725-9.
PubMed 33603133Gowrishankar M, Blair B, Rieder MJ. Dietary intake of sodium by children: Why it matters. Paediatr Child Health. 2020 Feb;25(1):47-61. doi: 10.1093/pch/pxz153. Epub 2020 Feb 6.
PubMed 32042243Lauridsen TG, Vase H, Starklint J, Graffe CC, Bech JN, Nielsen S, Pedersen EB. Increased renal sodium absorption by inhibition of prostaglandin synthesis during fasting in healthy man. A possible role of the epithelial sodium channels. BMC Nephrol. 2010 Oct 28;11:28. doi: 10.1186/1471-2369-11-28.
PubMed 21029429Rahmani E, Eftekhari MH, Fallahzadeh MH, Fararouei M, Massoumi SJ. Effect of vitamin D and omega-3 on nocturnal enuresis of 7-15-year-old children. J Pediatr Urol. 2018 Jun;14(3):257.e1-257.e6. doi: 10.1016/j.jpurol.2018.01.007. Epub 2018 Feb 5.
PubMed 29598883Matsuo T, Miyata Y, Sakai H. Effect of salt intake reduction on nocturia in patients with excessive salt intake. Neurourol Urodyn. 2019 Mar;38(3):927-933. doi: 10.1002/nau.23929. Epub 2019 Feb 1.
PubMed 30706965Sousa AS, Veiga ML, Braga AA, Carvalho MC, Barroso U Jr. Enuresis and overactive bladder in children: what is the relationship between these two conditions? Int Braz J Urol. 2016 Jul-Aug;42(4):798-802. doi: 10.1590/S1677-5538.IBJU.2015.0579.
PubMed 27564293Management of primary nocturnal enuresis. Paediatr Child Health. 2005 Dec;10(10):611-4. doi: 10.1093/pch/10.10.611. No abstract available.
PubMed 19668675