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Use of Sodium Bicarbonate in Patients Treated With Topiramate

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ClinicalTrials.gov Identifier: NCT03354507
Recruitment Status : Not yet recruiting
First Posted : November 28, 2017
Last Update Posted : November 28, 2017
Sponsor:
Information provided by (Responsible Party):

November 21, 2017
November 28, 2017
November 28, 2017
January 2018
December 2018   (Final data collection date for primary outcome measure)
Changes in measured urine parameters [ Time Frame: Baseline, then at 4 weeks ]
Spot urine sample will be tested for calcium, creatinine and citrate
Same as current
No Changes Posted
  • 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
  • Changes in frequency of seizures. [ Time Frame: Baseline, then at 4 weeks ]
    Changes in seizure entries in seizure diary
Same as current
Not Provided
Not Provided
 
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)
Effect of oral sodium bicarbonate therapy on renal tubular acidosis in epilepsy patients taking topiramate.
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.
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Epilepsy
  • Metabolic Acidosis
  • Tubular Acidosis; Renal
Dietary Supplement: Sodium bicarbonate
Sodium bicarbonate. See arms.
  • 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.

    Intervention: Dietary Supplement: Sodium bicarbonate
  • No Intervention: Control
    Patients will not receive treatment if they do not have metabolic acidosis at baseline.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
40
December 2018
December 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
2 Years to 18 Years   (Child, Adult)
No
Contact: Mandeep Sidhu, MD 19055212100 ext 6924 mandeep.sidhu@medportal.ca
Contact: Surejini Tharmaradinam, MD 19055212100 ext 6760 surejini.tharmaradinam@medportal.ca
Canada
 
 
NCT03354507
1137
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Mandeep Sidhu, McMaster Children's Hospital
McMaster Children's Hospital
Not Provided
Not Provided
McMaster Children's Hospital
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP