Use of Sodium Bicarbonate in Patients Treated With Topiramate

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03354507

Enrollment

Registered

2017-11-28

Start date

2018-01-31

Completion date

2018-12-31

Last updated

2017-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy, Metabolic Acidosis, Tubular Acidosis; Renal

Keywords

topiramate, epilepsy, sodium bicarbonate, urine alkalinization

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.

Interventions

DIETARY_SUPPLEMENTSodium bicarbonate

Sodium bicarbonate. See arms.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 18 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

Canada

Contacts

Primary ContactMandeep Sidhu, MD

mandeep.sidhu@medportal.ca19055212100

Backup ContactSurejini Tharmaradinam, MD

surejini.tharmaradinam@medportal.ca19055212100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026