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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
Sponsor:
Information provided by (Responsible Party):
Uma Bhosale, Maharashtra University of Health Sciences

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Folic Acid Drug: Saccharine Phase 3

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control group
Will receive Oral saccharine tablet daily for 1month along with their existing antiepileptic therapy
Drug: Saccharine
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




Primary Outcome Measures :
  1. Decrease in serum homocysteine levels by 2 µmol/l [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. 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.

  2. Change in baseline systolic blood pressure [ Time Frame: 1 month ]
    Change in baseline systolic blood pressure will be compared between placebo and test group.



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Ages Eligible for Study:   10 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed epileptic patients of either sex with age between 10-19 yrs (<19yrs), coming to the medicine Out Patient /In Patient Departments and undergoing AED therapy for more than 6 months.
  • Epileptics with high homocysteine levels i.e. > 10.9 µmol/L (Normal homocysteine levels are 4.3-9.9 µmol/L for male and 3.3-7.2 µmol/L for female adolescent and a high homocysteine concentration is deaned as at least 11.4 µmol/L for male and at least 10.4 µmol/L for female. Gender mean of high homocysteine concentration is 10.9 µmol/L) [5]

Exclusion Criteria:

  • Pregnancy and lactation
  • Patients with diabetes, Ischemic heart disease (IHD), stroke, malignancy and psychiatric diseases are excluded from study.
  • The patients receiving vitamin supplements or who had clinical evidence for an acute illness, renal dysfunction, thyroid dysfunction, chronic inflammatory diseases, inborn errors of homocysteine, cobalamin or folate metabolism, or any other condition known to interfere with homocysteine metabolism will be excluded
  • Patients who are already involved in any other trial.
  • Patients not willing to fill consent/ assent form are also excluded from study.

Information from the National Library of Medicine

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


Contacts
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Contact: UMA A. BHOSALE, MD 02024106 ext 148 umabhosale2000@gmail.com

Locations
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India
Smt. Kashibai Navale Medical College and General Hospital Not yet recruiting
Pune, Maharashtra, India, 411041
Contact: Uma A. Bhosale, MD    02024106 ext 148    umabhosale2000@gmail.com   
Sponsors and Collaborators
Maharashtra University of Health Sciences
Investigators
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Principal Investigator: UMA A. BHOSALE, MD Smt. Kashibai Navale Medical College and General Hospital

Additional Information:
Publications:

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Responsible Party: Uma Bhosale, Professor in Department of Pharmacology, SKNMC & GH, Pune-41, Maharashtra University of Health Sciences
ClinicalTrials.gov Identifier: NCT02318446     History of Changes
Other Study ID Numbers: LTRG/E-1/03/ 1210
First Posted: December 17, 2014    Key Record Dates
Last Update Posted: December 17, 2014
Last Verified: December 2014

Keywords provided by Uma Bhosale, Maharashtra University of Health Sciences:
Anti-epileptic drugs
Folic acid
Homocysteine

Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Folic Acid
Vitamin B Complex
Anticonvulsants
Hematinics
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs