Protocol summary

Summary
About 1/3 of the patients suffering from epilepsy cannot be controlled with proper pharmaceutical treatment. Ketogenic diet is an effective treatment for such patients. In this study, we select thirty children aged 1-5 year-old, recognized as intractable epilepsy that fails to respond to drug treatment, who applied to Children’s Medical Center in Tehran, during the first six months of the year 2014. Those should be qualified for receiving ketogenic diet, and prescribe them, as outpatients, a kind of ready-made ketogenic diet, called Ketocal Powder for a period of four months. The Ketocal formula will constitute the major daily diet of the patients, and their carbohydrate-content food will be minimized. Blood sampling were done at the beginning and end of intervention for measurement of some parameters, In addition, The ketone content of their urine will be checked daily. Those who can not complete the formula consumption and/or in case of severe complications will be excluded . The patients’ formula tolerance, complications, the effect of the Ketocal formula on reduction of seizures will be assesed clinically and also by electroencephalogram twice during the period of study. If this kind of powder proves to be effective, then, it may be prescribed as a proper, ready-made and accessible diet to the patients suffering from intractable epilepsy, leading to reduction in hospitalization and decrease the burden of the illness.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201210016907N5
Registration date: 2014-06-28, 1393/04/07
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-06-28, 1393/04/07
Registrant information
Name
Mahmoudreza Ashrafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6612 9252
Email address
ashrafim@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Siences
Expected recruitment start date
2014-05-27, 1393/03/06
Expected recruitment end date
2014-10-12, 1393/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of Ketocal formula on the frequency of seizure in 1-5-Year-Old children suffering from Intractable epilepsy to antiepileptic drugs.
Public title
Effect of ketocal formula on the seizure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having seizures which are intractable with at least two anti-epileptic medications, and having seizures once in every month, on average, in the last year; having no contraindication in respect of Ketogenic diet based on the reviewed sources. Exclusion criteria: Acute complications due to the treatment, leading to withholding the treatment.
Age
From 12 months old to 5 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Siences
Street address
Sixth floor, Headquarter for Tehran University of Medical Sciences, On the Corner of Keshavarz Blvd. and Qods Street, Keshavarz Blvd., Tehran, Iran
City
Tehran
Postal code
Approval date
2014-05-25, 1393/03/04
Ethics committee reference number
130/496

Health conditions studied

1

Description of health condition studied
Epilepsy
ICD-10 code
G40 Epilep
ICD-10 code description
Episodic and paroxysmal disorders

Primary outcomes

1

Description
Seizure frequency
Timepoint
Before intervention and during intervention
Method of measurement
Average of sezure frequency per week

Secondary outcomes

1

Description
Toerability to ketocal diet
Timepoint
During intervention
Method of measurement
Descriptional

2

Description
Blood lipid profile(cholestrol, teriglyceride, LDL, HDL)
Timepoint
At biginning and end of intervention
Method of measurement
Blood sampling and laboratory measurement

3

Description
Blood calcium
Timepoint
At biginning and end of intervention
Method of measurement
Blood sampling and laboratory measurement

4

Description
Serum vitamine 25 hydroxy vitamine D
Timepoint
At biginning and end of intrvention
Method of measurement
Blood sampling and laboratory measurement

5

Description
Side effects
Timepoint
Durin intervention
Method of measurement
Parents report

6

Description
Serum zinc
Timepoint
At biginning and end of interventon
Method of measurement
Blood sampling and laboratory measurement

7

Description
Blood glucose
Timepoint
At biginning and end of intervention and when the patient feels weakness
Method of measurement
Blood sampling and laboratory measurement and glucometery

8

Description
Blood alkalyn phosphatase
Timepoint
At biginning and end of intervention
Method of measurement
Blood sampling and laboratory measurement

9

Description
Blood urea
Timepoint
At biginning and end of intervention
Method of measurement
Blood sampling and laboratory measurement

10

Description
Plasma creatinine
Timepoint
At biginning and end of intervention
Method of measurement
Blood sampling and laboratory measurement

Intervention groups

1

Description
This intervention is conducted, without control group, and the same patients suffering from intractable epilepsy are studied prior to and after being fed with the Ketocal formula. The volume of the formula will gradually increase until Ketone appears in the urine. Then, the frequency of seizures per week, side effects and tolerability in the four months of prescription of the formula will be assessed. The frequency of seizures are compared with those occurred prior to the commencement of the treatment.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Children's Medical Center, Tehran
Full name of responsible person
Seyed Ahmad Hosseini
Street address
Children's Medical Center, Qarib street, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
NUTRICIA
Full name of responsible person
Mojdeh Zohari
Street address
No.10, 6th floor, Negar tower, Negar Alley, Vanak Square
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
NUTRICIA
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Ahmad Hosseini
Position
Fellowship of pediatrics neurology
Other areas of specialty/work
Street address
Children's Medical Center, Qarib Street, Tehran
City
Tehran
Postal code
Phone
+98 21 6693 5848
Fax
Email
parnianah@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahmmoud Reza Ashrafi
Position
Pediatrics neurologist, Professor of TUMS
Other areas of specialty/work
Street address
Children's Medical Center, Qarib street, Tehran
City
Tehran
Postal code
Phone
+98 21 6693 5848
Fax
Email
mr_ashrafi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Ahamd Hosseini
Position
Fellowship of pediatrics neurology
Other areas of specialty/work
Street address
Children's Medical Center, Qarib street, Tehran
City
Tehran
Postal code
Phone
+98 21 6693 5848
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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