Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202503801929185 Date of Registration: 04/03/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The possible role of folic acid and vitamin B12 in primary nocturnal enuresis.
Official scientific title Interventional Effects of folic acid and Vitamin B12 in Primary Nocturnal Enuresis in children aged 5-16 years: A Randomized, Double-Blind, Placebo-Controlled trial.
Brief summary describing the background and objectives of the trial While observational evidence suggests a strong link between folic acid and Vitamin B12 in Primary Nocturnal Enuresis, the evidence of a causal link through intervention studies is limited. To maximize the power of the interventional study to address the effect of folic acid and Vitamin B12 supplementation, we will conduct this interventional study on primary nocturnal enuresis children after excluding children aged below 5 years, patients with any chronic disease, and patients with other major clinical conditions. A full history was taken, and full clinical examination and laboratory investigations were done. Laboratory investigations included serum folic acid and vitamin B12 before and after intervention. The primary objective of this intervention is to assess whether folic acid and vitamin B12 plus regulating daily habits is superior to regulating daily habits alone in terms of nocturnal enuresis outcomes in children aged 5-16 years identified with primary nocturnal enuresis following screening. A secondary objective is assessing laboratory and symptomatic outcomes after intervention in children with primary nocturnal enuresis.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial
Anticipated trial start date 01/10/2023
Actual trial start date 01/10/2023
Anticipated date of last follow up 01/10/2024
Actual Last follow-up date 01/10/2024
Anticipated target sample size (number of participants) 18
Actual target sample size (number of participants) 35
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group folic acid 1mg\day for 10 days followed by 0.4 mg once daily. 3 months. Folic acid was given as tablets at 1mg\day for 10 days, followed by 0.4 mg once daily for 3 months. Folic acid tablets were reconstructed with water for children with lack of tablet compliance. the dose was defined according to The Harriet Lane HandBook 2023. 35
Experimental Group vitamin B12 100 mcg/day for 10 days, then 100 mcg once a week 3 months. Vitamin B12 was given as an intramuscular injection at 100 mcg/day for 10 days, then 100 mcg once a week for three months. the dose was defined according to The Harriet Lne TextBook 2023. 35
Control Group placebo 1 mg per kg per day 3 months placebo groups received the same regimen of placebo from a tabletof the same taste, color and amount identical in appearance to the folic supplementation with no active ingredients, packed in the same way as folic tablets prepared by trial pharmacist. 35 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
A monthly average of two or more enuretic episodes. Absent daytime wetting, no dry spells lasting more than 6 months. Not under medical treatment for nocturnal enuresis during the study. Patients less than 5 years. Patients with chronic diseases, neurological or urological anomalies. Previous recurrent urinary tract infections. Other major medical conditions. Adolescent: 13 Year(s)-17 Year(s),Child: 6 Year-12 Year 5 Year(s) 16 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/10/2023 Institutional Research Board of Menoufia Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
yassen abdel ghaffar shebin elkom 32511 Egypt
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/06/2023 Institutional Research Board of Menoufia Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
yassen abdel ghaffar shebin elkom 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome to assess whether folic acid and vitamin B12 plus regulating daily habits is superior to regulating daily habits alone in terms of nocturnal enuresis outcomes in children aged 5-16 years identified with primary nocturnal enuresis following screening. baseline and after 3 months
Secondary Outcome assessing laboratory and symptomatic outcomes after intervention in children with primary nocturnal enuresis. baseline and 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia faculty of medicine yassen abdel ghaffar shebien el kom 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self fund shebien el kom - yassen abdel ghaffar menofia 32511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine menoufia university yassen abdel ghaffar shebin ekom 32511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator asmaa zidan asmaa_zidan230@yahoo.com 201067226398 yassen abdel gaffar
City Postal code Country Position/Affiliation
shebin elkom 32511 Egypt postgraduate researcher
Role Name Email Phone Street address
Scientific Enquiries asmaa zidan asmaa_zidan230@yahoo.com 201067226398 yassen abdel gaffar
City Postal code Country Position/Affiliation
shebin elkom 32511 Egypt postgraduate researcher
Role Name Email Phone Street address
Public Enquiries asmaa zidan asmaa_zidan230@yahoo.com 201067226398 yassen abdel gaffar
City Postal code Country Position/Affiliation
shebin elkom 32511 Egypt postgraduate researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Clinical Study Report, Informed Consent Form, Statistical Analysis Plan, Study Protocol Researchers who provide a methodologically sound proposal after approval by an independent review committee
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Proposals should be directed to email : asmaa_zidan230@yahoo.com or asmaazidan230@gmail.com No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information