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Effect of ketocal formula on the seizure

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201210016907N5
Enrollment
30
Registered
2014-06-28
Start date
2014-05-27
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy. Episodic and paroxysmal disorders

Interventions

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 fo
Treatment - Other
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 f

Sponsors

NUTRICIA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Months to 5 Years

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Seizure frequency. Timepoint: Before intervention and during intervention. Method of measurement: Average of sezure frequency per week.

Secondary

MeasureTime frame
Toerability to ketocal diet. Timepoint: During intervention. Method of measurement: Descriptional.;Blood lipid profile(cholestrol, teriglyceride, LDL, HDL). Timepoint: At biginning and end of intervention. Method of measurement: Blood sampling and laboratory measurement.;Blood calcium. Timepoint: At biginning and end of intervention. Method of measurement: Blood sampling and laboratory measurement.;Serum vitamine 25 hydroxy vitamine D. Timepoint: At biginning and end of intrvention. Method of measurement: Blood sampling and laboratory measurement.;Side effects. Timepoint: Durin intervention. Method of measurement: Parents report.;Serum zinc. Timepoint: At biginning and end of interventon. Method of measurement: Blood sampling and laboratory measurement.;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.;Blood alkalyn phosphatase. Timepoint: At biginning and end of intervention. Method of measurement: Blood sampling and laboratory measurement.;Blood urea. Timepoint: At biginning and end of intervention. Method of measurement: Blood sampling and laboratory measurement.;Plasma creatinine. Timepoint: At biginning and end of intervention. Method of measurement: Blood sampling and laboratory measurement.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Ahmad Hosseini

Tehran University of Medical Sciences

parnianah@yahoo.com+98 21 6693 5848

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026