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Use of Sodium Bicarbonate in Patients Treated With Topiramate

Primary Purpose

Epilepsy, Metabolic Acidosis, Tubular Acidosis; Renal

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Sodium bicarbonate
Sponsored by
McMaster Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring topiramate, epilepsy, sodium bicarbonate, urine alkalinization

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with epilepsy receiving oral topiramate for a minimum of 3 months

Exclusion Criteria:

  • pre-existing renal impairments (ie nephropathy, primary nephritis)
  • receiving other medications or diet therapies that may influence renal function or urine acidity/ citrate concentration

Sites / Locations

  • McMaster Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Sodium Bicarbonate

Control

Arm Description

Patients will receive sodium bicarbonate for 4 weeks, based on pre-calculated weight based doses. Patients are selected if they have metabolic acidosis at baseline. < 24 kg : 1/4 teaspoon bid. 24 - 42 kg : 1/2 teaspoon bid. > 42kg : 3/4 teaspoon bid.

Patients will not receive treatment if they do not have metabolic acidosis at baseline.

Outcomes

Primary Outcome Measures

Changes in measured urine parameters
Spot urine sample will be tested for calcium, creatinine and citrate

Secondary Outcome Measures

Changes in measured blood parameters.
sodium, potassium, chloride, calcium, magnesium, phosphate, bicarbonate, alkaline phosphatase, urea, creatinine, venous blood gas
Changes in frequency of seizures.
Changes in seizure entries in seizure diary

Full Information

First Posted
November 21, 2017
Last Updated
November 24, 2017
Sponsor
McMaster Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03354507
Brief Title
Use of Sodium Bicarbonate in Patients Treated With Topiramate
Official Title
Use of Sodium Bicarbonate to Alkalinize Serum/Urine in Pediatric Patients Treated With Topiramate (Pilot Study)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2018 (Anticipated)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Effect of oral sodium bicarbonate therapy on renal tubular acidosis in epilepsy patients taking topiramate.
Detailed Description
Children on topiramate are at a risk of renal tubular acidosis and subsequent development of renal stones. Sodium bicarbonate has been shown to reduce renal tubular acidosis in other populations. To date, no data exist on the efficacy of correction of renal tubular acidosis in pediatric patients on topiramate. We are proposing to investigate the efficacy of 4 weeks of oral sodium bicarbonate therapy to reduce tubular acidosis in patients on topiramate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Metabolic Acidosis, Tubular Acidosis; Renal
Keywords
topiramate, epilepsy, sodium bicarbonate, urine alkalinization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sodium Bicarbonate
Arm Type
Experimental
Arm Description
Patients will receive sodium bicarbonate for 4 weeks, based on pre-calculated weight based doses. Patients are selected if they have metabolic acidosis at baseline. < 24 kg : 1/4 teaspoon bid. 24 - 42 kg : 1/2 teaspoon bid. > 42kg : 3/4 teaspoon bid.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients will not receive treatment if they do not have metabolic acidosis at baseline.
Intervention Type
Dietary Supplement
Intervention Name(s)
Sodium bicarbonate
Intervention Description
Sodium bicarbonate. See arms.
Primary Outcome Measure Information:
Title
Changes in measured urine parameters
Description
Spot urine sample will be tested for calcium, creatinine and citrate
Time Frame
Baseline, then at 4 weeks
Secondary Outcome Measure Information:
Title
Changes in measured blood parameters.
Description
sodium, potassium, chloride, calcium, magnesium, phosphate, bicarbonate, alkaline phosphatase, urea, creatinine, venous blood gas
Time Frame
Baseline, then at 4 weeks
Title
Changes in frequency of seizures.
Description
Changes in seizure entries in seizure diary
Time Frame
Baseline, then at 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with epilepsy receiving oral topiramate for a minimum of 3 months Exclusion Criteria: pre-existing renal impairments (ie nephropathy, primary nephritis) receiving other medications or diet therapies that may influence renal function or urine acidity/ citrate concentration
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mandeep Sidhu, MD
Phone
19055212100
Ext
6924
Email
mandeep.sidhu@medportal.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Surejini Tharmaradinam, MD
Phone
19055212100
Ext
6760
Email
surejini.tharmaradinam@medportal.ca
Facility Information:
Facility Name
McMaster Children's Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mandeep Sidhu, MD
Phone
9055212100
Ext
6924
Email
mandeep.sidhu@medportal.ca
First Name & Middle Initial & Last Name & Degree
Surejini Tharmaradinam, MD
Phone
9055212100
Ext
6760
Email
surejini.tharmaradinam@medportal.ca
First Name & Middle Initial & Last Name & Degree
Vladimir Belostotsky, MD
First Name & Middle Initial & Last Name & Degree
Brandon Meaney, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18691980
Citation
Ben-Menachem E, Sander JW, Stefan H, Schwalen S, Schauble B. Topiramate monotherapy in the treatment of newly or recently diagnosed epilepsy. Clin Ther. 2008 Jul;30(7):1180-95. doi: 10.1016/s0149-2918(08)80045-8.
Results Reference
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PubMed Identifier
19911682
Citation
Caudarella R, Vescini F. Urinary citrate and renal stone disease: the preventive role of alkali citrate treatment. Arch Ital Urol Androl. 2009 Sep;81(3):182-7.
Results Reference
background
PubMed Identifier
16200192
Citation
Coe FL, Evan A, Worcester E. Kidney stone disease. J Clin Invest. 2005 Oct;115(10):2598-608. doi: 10.1172/JCI26662.
Results Reference
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PubMed Identifier
24219102
Citation
Dell'Orto VG, Belotti EA, Goeggel-Simonetti B, Simonetti GD, Ramelli GP, Bianchetti MG, Lava SA. Metabolic disturbances and renal stone promotion on treatment with topiramate: a systematic review. Br J Clin Pharmacol. 2014 Jun;77(6):958-64. doi: 10.1111/bcp.12283.
Results Reference
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PubMed Identifier
19797458
Citation
Hall PM. Nephrolithiasis: treatment, causes, and prevention. Cleve Clin J Med. 2009 Oct;76(10):583-91. doi: 10.3949/ccjm.76a.09043.
Results Reference
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PubMed Identifier
13278397
Citation
HANLEY T, PLATTS MM. Observations on the metabolic effects of the carbonic anhydrase inhibitor diamox: mode and rate of recovery from the drug's action. J Clin Invest. 1956 Jan;35(1):20-30. doi: 10.1172/JCI103248. No abstract available.
Results Reference
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PubMed Identifier
19916989
Citation
Mirza N, Marson AG, Pirmohamed M. Effect of topiramate on acid-base balance: extent, mechanism and effects. Br J Clin Pharmacol. 2009 Nov;68(5):655-61. doi: 10.1111/j.1365-2125.2009.03521.x.
Results Reference
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PubMed Identifier
19622511
Citation
Moher D, Liberati A, Tetzlaff J, Altman DG; PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann Intern Med. 2009 Aug 18;151(4):264-9, W64. doi: 10.7326/0003-4819-151-4-200908180-00135. Epub 2009 Jul 20. No abstract available.
Results Reference
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PubMed Identifier
15811478
Citation
Silberstein SD, Ben-Menachem E, Shank RP, Wiegand F. Topiramate monotherapy in epilepsy and migraine prevention. Clin Ther. 2005 Feb;27(2):154-65. doi: 10.1016/j.clinthera.2005.02.013.
Results Reference
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PubMed Identifier
17877442
Citation
Vega D, Maalouf NM, Sakhaee K. Increased propensity for calcium phosphate kidney stones with topiramate use. Expert Opin Drug Saf. 2007 Sep;6(5):547-57. doi: 10.1517/14740338.6.5.547.
Results Reference
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PubMed Identifier
22783025
Citation
Wile D. Diuretics: a review. Ann Clin Biochem. 2012 Sep;49(Pt 5):419-31. doi: 10.1258/acb.2011.011281. Epub 2012 Jul 10.
Results Reference
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Use of Sodium Bicarbonate in Patients Treated With Topiramate

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