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Not yet recruitingNCT07876947Updated Oct 15, 2026

Potential Adjuvant Therapies for Children With Primary Nocturnal Enuresis

An interventional study of Dietary Salt Restriction and Omega Supplementation in Nocturnal Enuresis in Children and Primary Nocturnal Enuresis, sponsored by Cairo University. Not yet recruiting. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Updated Oct 15, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
5 Years to 12 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Nocturnal Enuresis in Children
  • Primary Nocturnal Enuresis

Keywords

  • Salt Restriction
  • Nocturnal Enuresis in children
  • Primary Nocturnal Enuresis
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,909 studies on the registry; 1,445 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Children with Primary Nocturnal enuresis
  • Age: above than 5 years
  • Both sexes
  • Children whose parents approve enrollment in the study

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Salt Restriction

    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.

    Behavioral: Dietary Salt Restriction

  • Experimental
    Omega Supplementation

    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.

    Dietary Supplement: Omega Supplementation

Interventions

  • BehavioralDietary Salt Restriction

    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.

  • Dietary supplementOmega Supplementation

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At baseline and at the end of the salt-restriction intervention

  2. 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.

    Time frame: At baseline and at the end of the salt-restriction intervention

Secondary outcomes

  1. 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.

    Time frame: At the start of omega supplementation and after 3 months of omega supplementation

  2. 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.

    Time frame: At the start of omega supplementation and after 3 months of omega supplementation

  3. 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.

    Time frame: At the end of the salt-restriction intervention and after 3 months of omega supplementation

07

Study locations

No study locations are listed for this record.

08

References and documents

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 33603133 ↗
  • Gowrishankar 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 32042243 ↗
  • Lauridsen 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 21029429 ↗
  • Rahmani 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 29598883 ↗
  • Matsuo 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 30706965 ↗
  • Sousa 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 27564293 ↗
  • Management 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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2026; primary completion for Jun 2027, 6 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 9, 2026
First posted
Oct 15, 2026
StartEst.
Dec 1, 2026
Primary completionEst.
Jun 1, 2027
CompletionEst.
Jun 15, 2027
Last update
Oct 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07876947
Lead sponsor
Cairo University
Responsible party
Raoth Nabil (Pediatrician, Cairo University) — Principal investigator
First posted
Oct 15, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Jun 1, 2027 (estimated)
Completion
Jun 15, 2027 (estimated)
Last update
Oct 15, 2026

Study contacts

Raoth Nabil, MD candidate and pediatric and
Contact
raooth.nabil@gmail.com
+201002351391
Dalia Sayed Mosallam, Professor of pediatrics
study chair · pediatrics and neonatology department , Cairo university
Omnia Rafaat Amin, Professor of pediatrics
study director · pediatrics and neonatology department , Cairo university
Hoda Atef Ibrahim, Lecturer of pediatrics
study director · pediatrics and neonatology department , Cairo university
Dina Mahmoud Nabil, Lecturer of clinical pathology
study director · clinical pathology department , Cairo university

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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