EpilepsyNCT03354507
Use of Sodium Bicarbonate in Patients Treated With Topiramate
A study testing Sodium bicarbonate in people with Epilepsy and Metabolic Acidosis, run by McMaster Children's Hospital at 1 site in Canada.
Trial summary
Effect of oral sodium bicarbonate therapy on renal tubular acidosis in epilepsy patients taking topiramate. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Epilepsy, Metabolic Acidosis, Tubular Acidosis; Renal
- What is being tested?
- Sodium bicarbonate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2018to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with epilepsy receiving oral topiramate for a minimum of 3 months
Who cannot join
- pre-existing renal impairments (ie nephropathy, primary nephritis)
- receiving other medications or diet therapies that may influence renal function or urine acidity/ citrate concentration
Trial locations and contacts
1 site in 1 country.
Canada1 site
McMaster Children's Hospital
Hamilton, Ontario, L8N 3Z5
Mandeep Sidhu, MD, 9055212100 ext. 6924, mandeep.sidhu@medportal.ca
Surejini Tharmaradinam, MD, 9055212100 ext. 6760, surejini.tharmaradinam@medportal.ca
About this study
Official title: 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.
Read the detailed 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.
- Conditions
- Epilepsy, Metabolic Acidosis, Tubular Acidosis; Renal
- Being tested
- Sodium bicarbonate
- Keywords
- topiramate, epilepsy, sodium bicarbonate, urine alkalinization
- Medical subject headings
- Epilepsy, Acidosis, Acidosis, Renal Tubular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium bicarbonateDietary supplement
Sodium bicarbonate. See arms.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Sodium bicarbonate |
| Control | No intervention | Patients will not receive treatment if they do not have metabolic acidosis at baseline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in measured urine parameters
Spot urine sample will be tested for calcium, creatinine and citrate
Measured: Baseline, then at 4 weeks
Secondary outcomes (2)
Changes in measured blood parameters.
sodium, potassium, chloride, calcium, magnesium, phosphate, bicarbonate, alkaline phosphatase, urea, creatinine, venous blood gas
Measured: Baseline, then at 4 weeks
Changes in frequency of seizures.
Changes in seizure entries in seizure diary
Measured: Baseline, then at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study startJan 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mandeep Sidhu, McMaster Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03354507
- Sponsor's protocol ID
- 1137
- Status last verified
- Nov 2017
- First submitted
- 21 Nov 2017
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18691980Caudarella 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.
PubMed 19911682Coe FL, Evan A, Worcester E. Kidney stone disease. J Clin Invest. 2005 Oct;115(10):2598-608. doi: 10.1172/JCI26662.
PubMed 16200192Dell'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.
PubMed 24219102Hall PM. Nephrolithiasis: treatment, causes, and prevention. Cleve Clin J Med. 2009 Oct;76(10):583-91. doi: 10.3949/ccjm.76a.09043.
PubMed 19797458HANLEY 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.
PubMed 13278397Mirza 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.
PubMed 19916989Moher 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.
PubMed 19622511Silberstein 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.
PubMed 15811478Vega 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.
PubMed 17877442Wile D. Diuretics: a review. Ann Clin Biochem. 2012 Sep;49(Pt 5):419-31. doi: 10.1258/acb.2011.011281. Epub 2012 Jul 10.
PubMed 22783025
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Sodium Bicarbonate to Alkalinize Serum/Urine in Pediatric Patients Treated With Topiramate (Pilot Study)
- ClinicalTrials.gov ID
- NCT03354507
- Acronym / sponsor ID
- 1137
- Conditions
- Epilepsy, Metabolic Acidosis, Tubular Acidosis; Renal
- Keywords
- topiramate, epilepsy, sodium bicarbonate, urine alkalinization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- McMaster Children's HospitalUniversity, hospital or other
- Study start
- Jan 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 28 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Effect of oral sodium bicarbonate therapy on renal tubular acidosis in epilepsy patients taking topiramate.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium Bicarbonate | Experimental | Dietary Supplement: Sodium bicarbonatePatients 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. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients with epilepsy receiving oral topiramate for a minimum of 3 months
Key exclusion criteria (2 listed)
- pre-existing renal impairments (ie nephropathy, primary nephritis)
- receiving other medications or diet therapies that may influence renal function or urine acidity/ citrate concentration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium bicarbonateSodium bicarbonate. See arms. | Dietary supplement | Sodium Bicarbonate |
Primary outcome
Changes in measured urine parameters
Time frame: Baseline, then at 4 weeks
Spot urine sample will be tested for calcium, creatinine and citrate
2 secondary outcomes
Changes in measured blood parameters.
Time frame: Baseline, then at 4 weeks
Changes in frequency of seizures.
Time frame: Baseline, then at 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
- Background: PubMed 18691980Ben-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.
- Background: PubMed 19911682Caudarella 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.
- Background: PubMed 16200192Coe FL, Evan A, Worcester E. Kidney stone disease. J Clin Invest. 2005 Oct;115(10):2598-608. doi: 10.1172/JCI26662.
- Background: PubMed 24219102Dell'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.
- Background: PubMed 19797458Hall PM. Nephrolithiasis: treatment, causes, and prevention. Cleve Clin J Med. 2009 Oct;76(10):583-91. doi: 10.3949/ccjm.76a.09043.
- Background: PubMed 13278397HANLEY 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.
- Background: PubMed 19916989Mirza 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.
- Background: PubMed 19622511Moher 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.
- Background: PubMed 15811478Silberstein 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.
- Background: PubMed 17877442Vega 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.
- Background: PubMed 22783025Wile D. Diuretics: a review. Ann Clin Biochem. 2012 Sep;49(Pt 5):419-31. doi: 10.1258/acb.2011.011281. Epub 2012 Jul 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium bicarbonate in people with Epilepsy and Metabolic Acidosis, run by McMaster Children's Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mandeep Sidhu, MD (19055212100 ext. 6924, mandeep.sidhu@medportal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in measured urine parameters (time frame: Baseline, then at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03354507, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2017.