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.|
|ClinicalTrials.gov Identifier: NCT03354507|
Recruitment Status : Not yet recruiting
First Posted : November 28, 2017
Last Update Posted : November 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy Metabolic Acidosis Tubular Acidosis; Renal||Dietary Supplement: Sodium bicarbonate||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Changes in measured urine parameters [ Time Frame: Baseline, then at 4 weeks ]Spot urine sample will be tested for calcium, creatinine and citrate
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT03354507
|Contact: Mandeep Sidhu, MD||19055212100 ext firstname.lastname@example.org|
|Contact: Surejini Tharmaradinam, MD||19055212100 ext email@example.com|
|McMaster Children's Hospital||Not yet recruiting|
|Hamilton, Ontario, Canada, L8N 3Z5|
|Contact: Mandeep Sidhu, MD 9055212100 ext 6924 firstname.lastname@example.org|
|Contact: Surejini Tharmaradinam, MD 9055212100 ext 6760 email@example.com|
|Principal Investigator: Vladimir Belostotsky, MD|
|Sub-Investigator: Brandon Meaney, MD|