Use of Sodium Bicarbonate in Patients Treated With Topiramate

Not Applicable

• Conditions: Metabolic Acidosis; Tubular Acidosis; Renal; Epilepsy
• Interventions: Dietary Supplement: Sodium bicarbonate

• Registration Number: NCT03354507
• Lead Sponsor: McMaster Children's Hospital

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.

Study Timeline

• Status Verified: 2017-11
• Study First Submitted: 2017-11-21
• Study First Submitted QC: 2017-11-24
• Last Update Submitted: 2017-11-24
• Study First Posted: 2017-11-28
• Last Update Posted: 2017-11-28
• Study Start: 2018-01
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium Bicarbonate	Sodium bicarbonate	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.

Primary Outcome Measures

Name	Time	Method
Changes in measured urine parameters	Baseline, then at 4 weeks	Spot urine sample will be tested for calcium, creatinine and citrate

Secondary Outcome Measures

Name	Time	Method
Changes in measured blood parameters.	Baseline, then at 4 weeks	sodium, potassium, chloride, calcium, magnesium, phosphate, bicarbonate, alkaline phosphatase, urea, creatinine, venous blood gas
Changes in frequency of seizures.	Baseline, then at 4 weeks	Changes in seizure entries in seizure diary

Trial Locations

Locations (1)

McMaster Children's Hospital; 🇨🇦 Hamilton, Ontario, Canada