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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control | No Intervention | Patients will not receive treatment if they do not have metabolic acidosis at baseline. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium bicarbonate | Dietary Supplement | Sodium bicarbonate. See arms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in measured urine parameters | Spot urine sample will be tested for calcium, creatinine and citrate | Baseline, then at 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in measured blood parameters. | sodium, potassium, chloride, calcium, magnesium, phosphate, bicarbonate, alkaline phosphatase, urea, creatinine, venous blood gas | Baseline, then at 4 weeks |
| Changes in frequency of seizures. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mandeep Sidhu, MD | Contact | 19055212100 | 6924 | mandeep.sidhu@medportal.ca |
| Surejini Tharmaradinam, MD | Contact | 19055212100 | 6760 | surejini.tharmaradinam@medportal.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster Children's Hospital | Hamilton | Ontario | L8N 3Z5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18691980 | Background | 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. | |
| 19911682 | 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. |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D000138 | Acidosis |
| D000141 | Acidosis, Renal Tubular |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000137 | Acid-Base Imbalance |
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| ID | Term |
|---|---|
| D017693 | Sodium Bicarbonate |
| ID | Term |
|---|---|
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
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Changes in seizure entries in seizure diary
| Baseline, then at 4 weeks |
| 16200192 | Background | Coe FL, Evan A, Worcester E. Kidney stone disease. J Clin Invest. 2005 Oct;115(10):2598-608. doi: 10.1172/JCI26662. |
| 24219102 | 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. |
| 19797458 | Background | Hall PM. Nephrolithiasis: treatment, causes, and prevention. Cleve Clin J Med. 2009 Oct;76(10):583-91. doi: 10.3949/ccjm.76a.09043. |
| 13278397 | 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. |
| 19916989 | 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. |
| 19622511 | 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. |
| 15811478 | 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. |
| 17877442 | 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. |
| 22783025 | 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. |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D015499 | Renal Tubular Transport, Inborn Errors |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007287 |
| Inorganic Chemicals |
| D017670 | Sodium Compounds |