Efficacy Study of Folic Acid Supplementation in Adolescent Epileptics
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|ClinicalTrials.gov Identifier: NCT02318446|
Recruitment Status : Unknown
Verified December 2014 by Uma Bhosale, Maharashtra University of Health Sciences.
Recruitment status was: Not yet recruiting
First Posted : December 17, 2014
Last Update Posted : December 17, 2014
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Drug: Folic Acid Drug: Saccharine||Phase 3|
Scientific background, significance and impact value of the project:
Homocysteine is a thiol‑containing amino acid formed as an intermediate product during the methionine metabolism. Re-methylation pathway recycles Homocysteine back to methionine and requires vitamin B12 and folic acid as cofactors.  The concentration of circulating total homocysteine is a sensitive marker of inadequate folate and vitamin B12 status. Elevated homocysteine concentrations are associated with an increased risk for cardiovascular (CV) disease.  The total homocysteine level is the lowest in children and an increase with age is higher in male sex.  The cutoffs for homocysteine level in adolescent range from 4.3 to 9.9 µmol/l, and hyperhomocysteinemia is defined as homocysteine >10.9 µmol/l.  Lower folate and higher homocysteine concentrations may put adolescent on AEDs at special risk for atherosclerosis in their adulthood.  This demands early intervention as Asian Indian adolescents are genetically more exposed to cadiovascular disease(CVD) risks, AED therapy is an additional risk for developing future CVDs. Adolescent epileptics on AED have to take it for long time, and homocysteine elevation itself has got epileptogenic potential and can cause the risk developing refractory epilepsy.  Literature search reveals several studies depicting role of vitamin B12 in regulation of blood homocysteine levels. [6, 7] However, the studies confirming role of folic acid supplementation in hyperhomocysteinemia and related CV diseases are fewer and scarce in AEDs induced hyperhomocysteinemia. Few studies have reported negative correlation between hyperhomocysteinemia and low folic acid levels in patients on AEDs.  At the same time few studies have reported effectiveness of folic acid supplementation to normalize the homocysteine levels.  Considering the results of various studies many doctors are now prescribing folic acid along with AEDs, although there is a scarcity of data from India. In this context, the present study is planned to study effect of folic acid supplementation on homocysteine levels and CV risk factors such as BP and lipids in adolescent epileptics taking AEDs.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Efficacy Study of Folic Acid Supplementation on Homocysteine Levels in Adolescent Epileptics Taking Antiepileptic Drugs: A Single Blind Randomized Controlled Clinical Trial|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||April 2016|
|Estimated Study Completion Date :||May 2016|
Placebo Comparator: Control group
Will receive Oral saccharine tablet daily for 1month along with their existing antiepileptic therapy
Placebo group(n=12) Existing Anti-epileptic Drugs + Oral saccharine 10 mg tablet daily for 1month
Other Name: Sugar free
Experimental: Test group
Will receive Oral Folic acid 1mg tablet daily for 1month along with their existing antiepileptic therapy
Drug: Folic Acid
Test group(n= 24) Existing Anti-epileptic Drugs + Oral Folic acid 1mg tablet daily for 1month
Other Name: Folvite
- Decrease in serum homocysteine levels by 2 µmol/l [ Time Frame: 1 month ]
- Change in baseline serum lipids [ Time Frame: 1 month ]Change in baseline serum lipids following Anti-epileptic therapy will be compared between placebo and test group.
- Change in baseline systolic blood pressure [ Time Frame: 1 month ]Change in baseline systolic blood pressure will be compared between placebo and test group.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02318446
|Contact: UMA A. BHOSALE, MD||02024106 ext firstname.lastname@example.org|
|Smt. Kashibai Navale Medical College and General Hospital||Not yet recruiting|
|Pune, Maharashtra, India, 411041|
|Contact: Uma A. Bhosale, MD 02024106 ext 148 email@example.com|
|Principal Investigator:||UMA A. BHOSALE, MD||Smt. Kashibai Navale Medical College and General Hospital|