Protocol summary
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Study aim
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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.
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Design
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Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with epilepsy aged 6 to 12 years. Exclusion criteria: Taking folate supplements or other therapies such as vitamins or antioxidants within the last 3 months, unwillingness to cooperate, metabolic diseases, chronic medical conditions including anemia and gastrointestinal disease associated with malabsorption, neuropsychological diseases and neurodegenerative disorders
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Intervention groups
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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.
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Main outcome variables
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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
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201704225623N110
Registration date:
2017-05-09, 1396/02/19
Registration timing:
retrospective
Last update:
2019-09-23, 1398/07/01
Update count:
1
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Registration date
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2017-05-09, 1396/02/19
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice chancellor for research, Kashan University of Medical Sciences
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Expected recruitment start date
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2015-03-17, 1393/12/26
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Expected recruitment end date
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2015-07-17, 1394/04/26
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Clinical trial of the effect of folate supplementation compared with the placebo on carotid intima-media thickness and metabolic profiles in patients with epilepsy
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Public title
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Effect of supplementation in treatment of patients with epilepsy
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Aged 2 to 12 years
Patients with epilepsy
Receiving carbamazepine monotherapy
Exclusion criteria:
Taking folate supplements or other therapies such as vitamins or antioxidants within the last 3 months
Unwillingness to cooperate
Metabolic diseases
Chronic medical conditions including anemia and gastrointestinal disease associated with malabsorption
Neuropsychological diseases, and neurodegenerative disorders
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Age
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From 2 years old to 12 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
54
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization will be done by the use of computer-generated random numbers.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2015-03-16, 1393/12/25
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Ethics committee reference number
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6011
Health conditions studied
1
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Description of health condition studied
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Epilepsy
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ICD-10 code
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G40
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ICD-10 code description
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Episodic and paroxysmal disorders
Primary outcomes
1
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Description
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Carotid intima-media thickness
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Sonography
Secondary outcomes
1
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Description
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Nitric oxide
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
2
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Description
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Malondialdehyde
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
3
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Description
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Hs-CRP
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Elisa kit
4
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Description
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Total antioxidant
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
Intervention groups
1
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Description
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Intervention group: Folate supplements (Tehran darou, Tehran, Iran), 5000 mg, daily, for 12 weeks orally.
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo tablet, daily for 12 weeks orally.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice chancellor for research, Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available