Use of Sodium Bicarbonate in Patients Treated With Topiramate

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03354507
• Other study ID #: 1137
• Status: Not yet recruiting
• Phase: N/A
• First received: November 21, 2017
• Last updated: November 24, 2017
• Start date: January 2018
• Est. completion date: December 2018

Study information

• Verified date: November 2017
• Source: McMaster Children's Hospital
• Contact: Mandeep Sidhu, MD
• Phone: 19055212100
• Email: mandeep.sidhu[@]medportal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Acidosis
• Acidosis, Renal Tubular
• Epilepsy
• Metabolic Acidosis
• Tubular Acidosis; Renal

Intervention

Dietary Supplement:
• Sodium bicarbonate
Sodium bicarbonate. See arms.

Locations

Country	Name	City	State
Canada	McMaster Children's Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster Children's Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (11)

Ben-Menachem E, Sander JW, Stefan H, Schwalen S, Schäuble B. Topiramate monotherapy in the treatment of newly or recently diagnosed epilepsy. Clin Ther. 2008 Jul;30(7):1180-95. Review. — View Citation

Caudarella R, Vescini F. Urinary citrate and renal stone disease: the preventive role of alkali citrate treatment. Arch Ital Urol Androl. 2009 Sep;81(3):182-7. Review. — View Citation

Coe FL, Evan A, Worcester E. Kidney stone disease. J Clin Invest. 2005 Oct;115(10):2598-608. Review. — View Citation

Dell'Orto VG, Belotti EA, Goeggel-Simonetti B, Simonetti GD, Ramelli GP, Bianchetti MG, Lava SA. Metabolic disturbances and renal stone promotion on treatment with topiramate: a systematic review. Br J Clin Pharmacol. 2014 Jun;77(6):958-64. doi: 10.1111/bcp.12283. Review. — View Citation

Hall PM. Nephrolithiasis: treatment, causes, and prevention. Cleve Clin J Med. 2009 Oct;76(10):583-91. doi: 10.3949/ccjm.76a.09043. Review. — View Citation

HANLEY T, PLATTS MM. Observations on the metabolic effects of the carbonic anhydrase inhibitor diamox: mode and rate of recovery from the drug's action. J Clin Invest. 1956 Jan;35(1):20-30. — View Citation

Mirza N, Marson AG, Pirmohamed M. Effect of topiramate on acid-base balance: extent, mechanism and effects. Br J Clin Pharmacol. 2009 Nov;68(5):655-61. doi: 10.1111/j.1365-2125.2009.03521.x. — View Citation

Moher D, Liberati A, Tetzlaff J, Altman DG; PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann Intern Med. 2009 Aug 18;151(4):264-9, W64. Epub 2009 Jul 20. — View Citation

Silberstein SD, Ben-Menachem E, Shank RP, Wiegand F. Topiramate monotherapy in epilepsy and migraine prevention. Clin Ther. 2005 Feb;27(2):154-65. Review. — View Citation

Vega D, Maalouf NM, Sakhaee K. Increased propensity for calcium phosphate kidney stones with topiramate use. Expert Opin Drug Saf. 2007 Sep;6(5):547-57. Review. — View Citation

Wile D. Diuretics: a review. Ann Clin Biochem. 2012 Sep;49(Pt 5):419-31. doi: 10.1258/acb.2011.011281. Epub 2012 Jul 10. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in measured urine parameters	Spot urine sample will be tested for calcium, creatinine and citrate	Baseline, then at 4 weeks
Secondary	Changes in measured blood parameters.	sodium, potassium, chloride, calcium, magnesium, phosphate, bicarbonate, alkaline phosphatase, urea, creatinine, venous blood gas	Baseline, then at 4 weeks
Secondary	Changes in frequency of seizures.	Changes in seizure entries in seizure diary	Baseline, then at 4 weeks