NCT02318446

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 17, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

December 17, 2014

Status Verified

December 1, 2014

Enrollment Period

1.1 years

First QC Date

December 10, 2014

Last Update Submit

December 16, 2014

Conditions

Epilepsy

Keywords

Anti-epileptic drugsFolic acidHomocysteine

Outcome Measures

Primary Outcomes (1)

  • Decrease in serum homocysteine levels by 2 µmol/l

    1 month

Secondary Outcomes (2)

  • Change in baseline serum lipids

    1 month

  • Change in baseline systolic blood pressure

    1 month

Study Arms (2)

Control group

PLACEBO COMPARATOR

Will receive Oral saccharine tablet daily for 1month along with their existing antiepileptic therapy

Drug: Saccharine

Test group

EXPERIMENTAL

Will receive Oral Folic acid 1mg tablet daily for 1month along with their existing antiepileptic therapy

Drug: Folic Acid

Interventions

Folic AcidDRUG

Test group(n= 24) Existing Anti-epileptic Drugs + Oral Folic acid 1mg tablet daily for 1month

Also known as: Folvite
Test group
SaccharineDRUG

Placebo group(n=12) Existing Anti-epileptic Drugs + Oral saccharine 10 mg tablet daily for 1month

Also known as: Sugar free
Control group

Eligibility Criteria

Age10 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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) \[5\]

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Smt. Kashibai Navale Medical College and General Hospital

Pune, Maharashtra, 411041, India

Location

Related Publications (11)

  • Hoffer LJ. Homocysteine remethylation and trans-sulfuration. Metabolism. 2004 Nov;53(11):1480-3. doi: 10.1016/j.metabol.2004.06.003.

    PMID: 15536605BACKGROUND

  • Selhub J, Miller JW. The pathogenesis of homocysteinemia: interruption of the coordinate regulation by S-adenosylmethionine of the remethylation and transsulfuration of homocysteine. Am J Clin Nutr. 1992 Jan;55(1):131-8. doi: 10.1093/ajcn/55.1.131.

    PMID: 1728812BACKGROUND

  • Selhub J, Jacques PF, Rosenberg IH, Rogers G, Bowman BA, Gunter EW, Wright JD, Johnson CL. Serum total homocysteine concentrations in the third National Health and Nutrition Examination Survey (1991-1994): population reference ranges and contribution of vitamin status to high serum concentrations. Ann Intern Med. 1999 Sep 7;131(5):331-9. doi: 10.7326/0003-4819-131-5-199909070-00003.

    PMID: 10475885BACKGROUND

  • Osganian SK, Stampfer MJ, Spiegelman D, Rimm E, Cutler JA, Feldman HA, Montgomery DH, Webber LS, Lytle LA, Bausserman L, Nader PR. Distribution of and factors associated with serum homocysteine levels in children: Child and Adolescent Trial for Cardiovascular Health. JAMA. 1999 Apr 7;281(13):1189-96. doi: 10.1001/jama.281.13.1189.

    PMID: 10199428BACKGROUND

  • Cheng LS, Prasad AN, Rieder MJ. Relationship between antiepileptic drugs and biological markers affecting long-term cardiovascular function in children and adolescents. Can J Clin Pharmacol. 2010 Winter;17(1):e5-46. Epub 2010 Jan 4.

    PMID: 20051609BACKGROUND

  • Sato Y, Ouchi K, Funase Y, Yamauchi K, Aizawa T. Relationship between metformin use, vitamin B12 deficiency, hyperhomocysteinemia and vascular complications in patients with type 2 diabetes. Endocr J. 2013;60(12):1275-80. doi: 10.1507/endocrj.ej13-0332. Epub 2013 Sep 8.

    PMID: 24018893BACKGROUND

  • Satyanarayana A, Balakrishna N, Pitla S, Reddy PY, Mudili S, Lopamudra P, Suryanarayana P, Viswanath K, Ayyagari R, Reddy GB. Status of B-vitamins and homocysteine in diabetic retinopathy: association with vitamin-B12 deficiency and hyperhomocysteinemia. PLoS One. 2011;6(11):e26747. doi: 10.1371/journal.pone.0026747. Epub 2011 Nov 1.

    PMID: 22069468BACKGROUND

  • Coppola G, Ingrosso D, Operto FF, Signoriello G, Lattanzio F, Barone E, Matera S, Verrotti A. Role of folic acid depletion on homocysteine serum level in children and adolescents with epilepsy and different MTHFR C677T genotypes. Seizure. 2012 Jun;21(5):340-3. doi: 10.1016/j.seizure.2012.02.011. Epub 2012 Mar 16.

    PMID: 22425007BACKGROUND

  • Linnebank M, Moskau S, Semmler A, Widman G, Stoffel-Wagner B, Weller M, Elger CE. Antiepileptic drugs interact with folate and vitamin B12 serum levels. Ann Neurol. 2011 Feb;69(2):352-9. doi: 10.1002/ana.22229. Epub 2011 Jan 19.

    PMID: 21246600BACKGROUND

  • De Lourdes Levy M, Larcher V, Kurz R; Ethics Working Group of the Confederation of European Specialists in Paediatrics (CESP). Informed consent/assent in children. Statement of the Ethics Working Group of the Confederation of European Specialists in Paediatrics (CESP). Eur J Pediatr. 2003 Sep;162(9):629-33. doi: 10.1007/s00431-003-1193-z. Epub 2003 Jul 19.

    PMID: 12884032BACKGROUND

  • Age limits and adolescents. Paediatr Child Health. 2003 Nov;8(9):577-8. doi: 10.1093/pch/8.9.577. No abstract available.

    PMID: 20019831BACKGROUND

Related Links

MeSH Terms

Conditions

Epilepsy

Interventions

Folic Acid

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • UMA A. BHOSALE, MD

    Smt. Kashibai Navale Medical College and General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

UMA A. BHOSALE, MD

CONTACT

02024106umabhosale2000@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Department of Pharmacology, SKNMC & GH, Pune-41

Study Record Dates

First Submitted

December 10, 2014

First Posted

December 17, 2014

Study Start

March 1, 2015

Primary Completion

April 1, 2016

Study Completion

May 1, 2016

Last Updated

December 17, 2014

Record last verified: 2014-12

Locations

IN(1)