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 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201704002060106 Date of Approval: 22/02/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Serum Folic Acid and Vitamin B12 in children with Idiopathic Epilepsy and their relation to Seizure Control and Cognitive functions
Official scientific title Assessment of Serum Folic Acid and Vitamin B12 in children with Idiopathic Epilepsy: Relation to Seizure Control and Cognitive functions
Brief summary describing the background and objectives of the trial The study aims to estimate folic acid & vitamin B12 level among children with idiopathic epilepsy and find out its relation to seizure control as well as the cognitive functions.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied idiopathic epilepsy,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 24/11/2015
Actual trial start date 24/11/2015
Anticipated date of last follow up 24/05/2016
Actual Last follow-up date 24/05/2016
Anticipated target sample size (number of participants) 16
Actual target sample size (number of participants) 50
Recruitment status Completed
Publication URL Serum Folic Acid and Vitamin B12 in children with Idiopathic Epilepsy and their relation to Seizure Control and Cognitive functions
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
Parallel: different groups receive different interventions at same time during study Non-randomised non random Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group folic acid and Vit B12 supplementation 5mg to all cases once daily 3 months vitamin supplemetation 25
Control Group Not intervention 3 months No intervention as these are healthy children 25 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-Drug resistant epilepsy: failure of adequate trials of two or more tolerated, appropriately chosen and used AED schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom which is defined as freedom from all seizures, including auras, for at least three times the longest pre-treatment interseizure interval or 12 months. 2- Age: 5-18 years. 1-Neurological, endocrinal or any systemic disease other than epilepsy. 2- Symptomatic and cryptogenic epilepsy. 3- Nutritional status impairments. (Z score ¿ -2SD) 4- Intake of nutritional supplements like vitamins and minerals. 5 Year(s) 18 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 24/01/2017 faculty of medicine ain shams university
Ethics Committee Address
Street address City Postal code Country
al abbasseya cairo +20 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome decrease severity of epilepsy 3 months
Primary Outcome decrease frequency of epilepsy 3 months
Primary Outcome improve cognitive function test 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Pediatric Neurology Clinic, Ain Shams University al abbasseya cairo +20 Egypt
Pediatric oupatient clinicl of Ain-Shams University hospital al Abbasseya Cairo +20 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
al ezaby pharmacy cairo cairo +20 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine ain shams university al abbasseya cairo +20 Egypt University
Secondary Sponsor Faculty of Medicine, Cairo University Cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
prof. Neveen tawakol Younis cairo cairo +20 Egypt
Dr. Iman Ali Abd El Hamid cairo cairo +20 Egypt
Dr. Mennattallah Osama Shata cairo cairo +20 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mona saleh monahassan202mh.mh@gmail.com +20 01007491427 cairo
City Postal code Country Position/Affiliation
cairo +20 Egypt candidate
Role Name Email Phone Street address
Scientific Enquiries Iman Abd El Hamid Dr_imana30@yahoo.com +20 01001722254 cairo
City Postal code Country Position/Affiliation
cairo +20 Egypt assistant professor
Role Name Email Phone Street address
Scientific Enquiries neveen younis neveen_tawakol@yahoo.com +20 01099694456 cairo
City Postal code Country Position/Affiliation
cairo +20 Egypt professor of pediatrics
REPORTING
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Result URL Hyperlinks
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