Use of Sodium Bicarbonate in Patients Treated With Topiramate

NCT03354507 | Unknown DMC

• 1 other identifier: 1137
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Epilepsy; Metabolic Acidosis; Tubular Acidosis; Renal

Keywords

topiramate; epilepsy; sodium bicarbonate; urine alkalinization

Outcome Measures

Primary Outcomes (1)

• Changes in measured urine parameters

  Spot urine sample will be tested for calcium, creatinine and citrate

  Baseline, then at 4 weeks

Secondary Outcomes (2)

• Changes in measured blood parameters.

  Baseline, then at 4 weeks

• Changes in frequency of seizures.

  Baseline, then at 4 weeks

Study Arms (2)

Sodium Bicarbonate

EXPERIMENTAL

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

Control

NO INTERVENTION

Patients will not receive treatment if they do not have metabolic acidosis at baseline.

Interventions

Sodium bicarbonate DIETARY_SUPPLEMENT

Sodium bicarbonate. See arms.

Sodium Bicarbonate

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with epilepsy receiving oral topiramate for a minimum of 3 months

You may not qualify if:

• pre-existing renal impairments (ie nephropathy, primary nephritis)
• receiving other medications or diet therapies that may influence renal function or urine acidity/ citrate concentration

Sponsors & Collaborators

• McMaster Children's Hospital: lead

Study Sites (1)

McMaster Children's Hospital

Hamilton, Ontario, L8N 3Z5, Canada

Location

Related Publications (11)

• Ben-Menachem E, Sander JW, Stefan H, Schwalen S, Schauble B. Topiramate monotherapy in the treatment of newly or recently diagnosed epilepsy. Clin Ther. 2008 Jul;30(7):1180-95. doi: 10.1016/s0149-2918(08)80045-8.

  PMID: 18691980 BACKGROUND

• 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.

  PMID: 19911682 BACKGROUND

• Coe FL, Evan A, Worcester E. Kidney stone disease. J Clin Invest. 2005 Oct;115(10):2598-608. doi: 10.1172/JCI26662.

  PMID: 16200192 BACKGROUND

• 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.

  PMID: 24219102 BACKGROUND

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

  PMID: 19797458 BACKGROUND

• 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. doi: 10.1172/JCI103248. No abstract available.

  PMID: 13278397 BACKGROUND

• 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.

  PMID: 19916989 BACKGROUND

• 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. doi: 10.7326/0003-4819-151-4-200908180-00135. Epub 2009 Jul 20. No abstract available.

  PMID: 19622511 BACKGROUND

• Silberstein SD, Ben-Menachem E, Shank RP, Wiegand F. Topiramate monotherapy in epilepsy and migraine prevention. Clin Ther. 2005 Feb;27(2):154-65. doi: 10.1016/j.clinthera.2005.02.013.

  PMID: 15811478 BACKGROUND

• 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. doi: 10.1517/14740338.6.5.547.

  PMID: 17877442 BACKGROUND

• 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.

  PMID: 22783025 BACKGROUND

MeSH Terms

Conditions

Epilepsy; Acidosis; Acidosis, Renal Tubular

Interventions

Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Renal Tubular Transport, Inborn Errors; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Mandeep Sidhu, MD

CONTACT

19055212100; mandeep.sidhu@medportal.ca

Surejini Tharmaradinam, MD

CONTACT

19055212100; surejini.tharmaradinam@medportal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: November 28, 2017
• Study Start: January 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: November 28, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)