Use of Sodium Bicarbonate in Patients Treated With Topiramate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03354507
Recruitment Status : Not yet recruiting
First Posted : November 28, 2017
Last Update Posted : November 28, 2017
Information provided by (Responsible Party):
Mandeep Sidhu, McMaster Children's Hospital

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

Condition or disease Intervention/treatment Phase
Epilepsy Metabolic Acidosis Tubular Acidosis; Renal Dietary Supplement: Sodium bicarbonate Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Sodium Bicarbonate to Alkalinize Serum/Urine in Pediatric Patients Treated With Topiramate (Pilot Study)
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: 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.

Dietary Supplement: Sodium bicarbonate
Sodium bicarbonate. See arms.

No Intervention: Control
Patients will not receive treatment if they do not have metabolic acidosis at baseline.

Primary Outcome Measures :
  1. Changes in measured urine parameters [ Time Frame: Baseline, then at 4 weeks ]
    Spot urine sample will be tested for calcium, creatinine and citrate

Secondary Outcome Measures :
  1. Changes in measured blood parameters. [ Time Frame: Baseline, then at 4 weeks ]
    sodium, potassium, chloride, calcium, magnesium, phosphate, bicarbonate, alkaline phosphatase, urea, creatinine, venous blood gas

  2. Changes in frequency of seizures. [ Time Frame: Baseline, then at 4 weeks ]
    Changes in seizure entries in seizure diary

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03354507

Contact: Mandeep Sidhu, MD 19055212100 ext 6924
Contact: Surejini Tharmaradinam, MD 19055212100 ext 6760

Canada, Ontario
McMaster Children's Hospital Not yet recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Mandeep Sidhu, MD    9055212100 ext 6924   
Contact: Surejini Tharmaradinam, MD    9055212100 ext 6760   
Principal Investigator: Vladimir Belostotsky, MD         
Sub-Investigator: Brandon Meaney, MD         
Sponsors and Collaborators
McMaster Children's Hospital


Responsible Party: Mandeep Sidhu, Resident Physician, McMaster Children's Hospital Identifier: NCT03354507     History of Changes
Other Study ID Numbers: 1137
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mandeep Sidhu, McMaster Children's Hospital:
sodium bicarbonate
urine alkalinization

Additional relevant MeSH terms:
Acidosis, Renal Tubular
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Acid-Base Imbalance
Metabolic Diseases
Renal Tubular Transport, Inborn Errors
Kidney Diseases
Urologic Diseases
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents