Use of Sodium Bicarbonate in Patients Treated With Topiramate

McMaster Children's Hospital

Status: Unknown

Conditions: Tubular Acidosis; Renal; Epilepsy; Metabolic Acidosis

Treatments: Dietary Supplement: Sodium bicarbonate

Study type: Interventional

Funder types: Other

Identifiers

NCT03354507

1137

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Sodium Bicarbonate

Experimental group

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.

Treatment:

Dietary Supplement: Sodium bicarbonate

Control

No Intervention group

Description:

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