Use of Sodium Bicarbonate in Patients Treated With Topiramate

Study Overview
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Brief Summary
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Effect of oral sodium bicarbonate therapy on renal tubular acidosis in epilepsy patients taking topiramate.

Detailed Description
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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.

Official Title
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Use of Sodium Bicarbonate to Alkalinize Serum/Urine in Pediatric Patients Treated With Topiramate (Pilot Study)

Conditions
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Epilepsy, Metabolic Acidosis, Tubular Acidosis; Renal

Intervention / Treatment
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* Dietary Supplement: Sodium bicarbonate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sodium Bicarbonate<br>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. | Dietary Supplement: Sodium bicarbonate<br>* Sodium bicarbonate. See arms.<br>|
| No Intervention: Control<br>Patients will not receive treatment if they do not have metabolic acidosis at baseline. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in measured urine parameters | Spot urine sample will be tested for calcium, creatinine and citrate | Baseline, then at 4 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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topiramate, epilepsy, sodium bicarbonate, urine alkalinization