Clinical trial of the effect of folate supplementation compared with the placebo on carotid intima-media thickness and metabolic profiles in patients with epilepsy
Objective: The aim of this study is to determine the effects of folate supplementation on carotid intima-media thickness and metabolic profiles in patients with epilepsy. Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with epilepsy aged 6 to 12 years. Exclusion criteria: Unwillingness to cooperate. Population and sample size: Among patients with epilepsy referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, 54 patients will be selected according to inclusion and exclusion criteria. Intervention: Patients will be assigned into two groups to receive folate (n=27) or placebo (n=27). Folate and placebos tablets are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and end of the intervention: 12 weeks. Outcomes: Carotid intima-media thickness (primary outcome) and biomarkers of inflammation and oxidative stress (secondary outcomes) will be quantified at study baseline and end-of-trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201704225623N110
Registration date:2017-05-09, 1396/02/19
Registration timing:retrospective
Last update:
Update count:1
Registration date
2017-05-09, 1396/02/19
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2015-03-17, 1393/12/26
Expected recruitment end date
2016-03-16, 1394/12/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of folate supplementation compared with the placebo on carotid intima-media thickness and metabolic profiles in patients with epilepsy
Public title
Effect of supplementation in treatment of patients with epilepsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with epilepsy; aged 6 to 12 years.
Exclusion criteria: Unwillingness to cooperate.
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Postal code
Approval date
2015-03-16, 1393/12/25
Ethics committee reference number
6011
Health conditions studied
1
Description of health condition studied
Epilepsy
ICD-10 code
G40
ICD-10 code description
Episodic and paroxysmal disorders
Primary outcomes
1
Description
Carotid intima-media thickness
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Sonography
Secondary outcomes
1
Description
Nitric oxide
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
2
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
3
Description
Hs-CRP
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
4
Description
Total antioxidant
Timepoint
At the beginning of the study and after 12 weeks of intervention