A Phase 3 interventional study of Folic Acid and Saccharine in Epilepsy, sponsored by Maharashtra University of Health Sciences. Status unknown at 1 site in India. Open to participants aged 10 Years to 19 Years. Per ClinicalTrials.gov, last updated 2014-12-17.
Sponsored by Maharashtra University of Health Sciences · Phase 3, Interventional, and Prevention
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 anti-epileptic drugs (AEDs).
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. [1] 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. [2] The total homocysteine level is the lowest in children and an increase with age is higher in male sex. [2] 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. [3] Lower folate and higher homocysteine concentrations may put adolescent on AEDs at special risk for atherosclerosis in their adulthood. [4] 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. [5] 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. [8] At the same time few studies have reported effectiveness of folic acid supplementation to normalize the homocysteine levels. [9] 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.
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's planned enrollment of 36 is below the median of 50 across 1,206 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →Maharashtra University of Health Sciences is the lead sponsor of 9 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Will receive Oral saccharine tablet daily for 1month along with their existing antiepileptic therapy
Drug: Saccharine
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
Also known as: Folvite
Placebo group(n=12) Existing Anti-epileptic Drugs + Oral saccharine 10 mg tablet daily for 1month
Also known as: Sugar free
Decrease in serum homocysteine levels by 2 µmol/l
Time frame: 1 month
Change in baseline serum lipids
Change in baseline serum lipids following Anti-epileptic therapy will be compared between placebo and test group.
Time frame: 1 month
Change in baseline systolic blood pressure
Change in baseline systolic blood pressure will be compared between placebo and test group.
Time frame: 1 month
This study is status unknown, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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Maharashtra University of Health Sciences