AlkalosisPhase 3NCT01835912
Chronic Versus Acute Dosing of Sodium Citrate for Swimming 200m
A Phase 3 study testing Sodium Citrate Dihydrate in people with Alkalosis, run by Brock University at 1 site in Canada.
Trial summary
Ingestion of sodium citrate (Na-Cit), an alkalizing agent, increases extracellular pH via liver oxidation by decreasing [H+] and increasing bicarbonate concentration (HCO3-). Studies have confirmed that increasing extracellular pH promotes the efflux of La- and H+ from active muscles. Read more about this study
- Who is it for?
- Ages 13 to 17 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alkalosis
- What is being tested?
- Sodium Citrate Dihydrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2012to Apr 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 13 to 17 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 13-17
- Male
- Regional, provincial and national level swimmers
Who cannot join
- Females
- Level of swimming below regional level standards
- Caffeine before trials
- Chronic health concerns
- Health problems before or during the course of the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chronic vs. Acute Ingestion of Sodium Citrate: a Randomised Placebo Controlled Cross-over Trial for Swimming a 200 Metres in Well-trained Swimmers Age 13-17
Ingestion of sodium citrate (Na-Cit), an alkalizing agent, increases extracellular pH via liver oxidation by decreasing [H+] and increasing bicarbonate concentration (HCO3-). Studies have confirmed that increasing extracellular pH promotes the efflux of La- and H+ from active muscles. This is due to an increase in activity of the pH sensitive monocarboxylate transporter as the gradient of intracellular versus extracellular H+ increases. Therefore, artificially inducing alkalosis prior to anaerobic exercise may reduce intracellular acidosis and increase the time to fatigue - defined as a decrease in force production with an increased perception of effort. The investigators will test the null hypothesis that sodium citrate ingestion (chronic and acute) will not have an effect on exercise performance compared to placebo.
Read the detailed description
Anaerobic glycolysis quickly provides adenosine triphosphate (ATP) for muscular contraction during high intensity, short duration exercise. The fast rate of glycolysis during anaerobic exercise results in pyruvate formation exceeding pyruvate oxidation resulting in a build up of lactic acid. Lactic acid dissociates quickly to lactate (La-) and hydrogen ion (H+) which causes a decrease in muscle and blood pH. The increase in H+ causes impaired release of calcium from the sarcoplasmic reticulum and calcium ion binding which inhibits the coupling of actin and myosin.
Ingestion of sodium citrate (Na-Cit), an alkalizing agent, increases extracellular pH via liver oxidation by decreasing [H+] and increasing bicarbonate concentration (HCO3-). Studies have confirmed that increasing extracellular pH promotes the efflux of La- and H+ from active muscles. This is due to an increase in activity of the pH sensitive monocarboxylate transporter as the gradient of intracellular versus extracellular H+ increases. Therefore, artificially inducing alkalosis prior to anaerobic exercise may reduce intracellular acidosis and increase the time to fatigue - defined as a decrease in force production with an increased perception of effort. Furthermore, Cit- enters the cell through the Plasma Membrane Citrate Transporter and in the cell Cit- is involved in a number of processes: i) intermediary in the Krebs Cycle, ii) transports acetyl-Co-enzyme A (CoA)from the mitochondria to the cytosol for fatty-acid synthesis, iii) negative allosteric effector of phosphofructokinase, iv) anionic effect on membrane potential can cause a reduction in the contraction threshold.
Researchers have studied sodium bicarbonate and Na-Cit as potential alkalizing agents. Na-Cit has been studied in few sports over a broad array of doses, times, and distances with inconclusive results. McNaughton et al. researched the optimal doses and durations for Na-Cit to be potentially beneficial to performance. They concluded that 0.3-0.5g/kg, 90-120 minutes prior to maximal effort are the optimal conditions for potential ergogenic effect. The only reported side effect was gastrointestinal (GI) discomfort in a 3 of the 8 subjects. However, it seems Na-Cit is handled better than the more commonly employed sodium bicarbonate.
The investigators will test the null hypothesis that sodium citrate ingestion (chronic and acute) will not have an effect on exercise performance compared to placebo.
- Conditions
- Alkalosis
- Being tested
- Sodium Citrate Dihydrate
- Keywords
- performance, speed, exertion
- Medical subject headings
- Alkalosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Citrate DihydrateOther
Also called CAS: 6132-04-3
Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)
| Study group | Role | What they receive |
|---|---|---|
| Flavoured water placebo for acute dosing | Placebo comparator | 500 milliliters flavoured water (placebo for the acute dosing intervention of sodium citrate) Receives: Other: Sodium Citrate Dihydrate |
| Sodium Citrate Dihydrate Acute | Experimental | dose: 0.5 g/kg of body mass dissolved in 500 milliliters of flavoured water Receives: Other: Sodium Citrate Dihydrate |
| Flavoured water placebo chronic dosing | Placebo comparator | 500 milliliters flavoured water (placebo for the chronic dosing intervention of sodium citrate) Receives: Other: Sodium Citrate Dihydrate |
| Sodium Citrate Dihydrate Chronic | Experimental | 3 days of 0.1g/kg of body mass of sodium citrate and 4th day at 0.3 g/kg of body mass of sodium citrate in 500 milliliters of flavoured water Receives: Other: Sodium Citrate Dihydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time
time to complete 200 metre swimming performances in seconds
Participants chose type of swim stroke to swim a maximal effort 200 metre performance
Measured: once each 200m performance
Secondary outcomes (1)
Lactate
lactate measured at 3min post trial
Measured: 3 min post performance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2013 (estimated)
- Study startSep 2012
- Primary completionMar 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AlkalosisStudies 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 3
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brock University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Colin Russell, Brock University
- Investigators
- Nota Klentrou, PhD, Study director, Brock University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01835912
- Sponsor's protocol ID
- 12-009
- Status last verified
- Jul 2014
- First submitted
- 10 Apr 2013
- Last updated
- 24 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Russell C, Papadopoulos E, Mezil Y, Wells GD, Plyley MJ, Greenway M, Klentrou P. Acute versus chronic supplementation of sodium citrate on 200 m performance in adolescent swimmers. J Int Soc Sports Nutr. 2014 Jun 12;11:26. doi: 10.1186/1550-2783-11-26. eCollection 2014.
PubMed 24944546
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic vs. Acute Ingestion of Sodium Citrate: a Randomised Placebo Controlled Cross-over Trial for Swimming a 200 Metres in Well-trained Swimmers Age 13-17
- ClinicalTrials.gov ID
- NCT01835912
- Acronym / sponsor ID
- 12-009
- Conditions
- Alkalosis
- Keywords
- performance, speed, exertion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Brock UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 19 Apr 2013 (estimated)
- Results
- Posted 24 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ingestion of sodium citrate (Na-Cit), an alkalizing agent, increases extracellular pH via liver oxidation by decreasing [H+] and increasing bicarbonate concentration (HCO3-). Studies have confirmed that increasing extracellular pH promotes the efflux of La- and H+ from active muscles. This is due to an increase in activity of the pH sensitive monocarboxylate transporter as the gradient of intracellular versus extracellular H+ increases. Therefore, artificially inducing alkalosis prior to anaerobic exercise may reduce intracellular acidosis and increase the time to fatigue - defined as a decrease in force production with an increased perception of effort. The investigators will test the null hypothesis that sodium citrate ingestion (chronic and acute) will not have an effect on exercise performance compared to placebo.
Detailed description
Anaerobic glycolysis quickly provides adenosine triphosphate (ATP) for muscular contraction during high intensity, short duration exercise. The fast rate of glycolysis during anaerobic exercise results in pyruvate formation exceeding pyruvate oxidation resulting in a build up of lactic acid. Lactic acid dissociates quickly to lactate (La-) and hydrogen ion (H+) which causes a decrease in muscle and blood pH. The increase in H+ causes impaired release of calcium from the sarcoplasmic reticulum and calcium ion binding which inhibits the coupling of actin and myosin.
Ingestion of sodium citrate (Na-Cit), an alkalizing agent, increases extracellular pH via liver oxidation by decreasing [H+] and increasing bicarbonate concentration (HCO3-). Studies have confirmed that increasing extracellular pH promotes the efflux of La- and H+ from active muscles. This is due to an increase in activity of the pH sensitive monocarboxylate transporter as the gradient of intracellular versus extracellular H+ increases. Therefore, artificially inducing alkalosis prior to anaerobic exercise may reduce intracellular acidosis and increase the time to fatigue - defined as a decrease in force production with an increased perception of effort. Furthermore, Cit- enters the cell through the Plasma Membrane Citrate Transporter and in the cell Cit- is involved in a number of processes: i) intermediary in the Krebs Cycle, ii) transports acetyl-Co-enzyme A (CoA)from the mitochondria to the cytosol for fatty-acid synthesis, iii) negative allosteric effector of phosphofructokinase, iv) anionic effect on membrane potential can cause a reduction in the contraction threshold.
Researchers have studied sodium bicarbonate and Na-Cit as potential alkalizing agents. Na-Cit has been studied in few sports over a broad array of doses, times, and distances with inconclusive results. McNaughton et al. researched the optimal doses and durations for Na-Cit to be potentially beneficial to performance. They concluded that 0.3-0.5g/kg, 90-120 minutes prior to maximal effort are the optimal conditions for potential ergogenic effect. The only reported side effect was gastrointestinal (GI) discomfort in a 3 of the 8 subjects. However, it seems Na-Cit is handled better than the more commonly employed sodium bicarbonate.
The investigators will test the null hypothesis that sodium citrate ingestion (chronic and acute) will not have an effect on exercise performance compared to placebo.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Flavoured water placebo for acute dosing | Placebo comparator | Other: Sodium Citrate Dihydrate500 milliliters flavoured water (placebo for the acute dosing intervention of sodium citrate) |
| Sodium Citrate Dihydrate Acute | Experimental | Other: Sodium Citrate Dihydratedose: 0.5 g/kg of body mass dissolved in 500 milliliters of flavoured water |
| Flavoured water placebo chronic dosing | Placebo comparator | Other: Sodium Citrate Dihydrate500 milliliters flavoured water (placebo for the chronic dosing intervention of sodium citrate) |
| Sodium Citrate Dihydrate Chronic | Experimental | Other: Sodium Citrate Dihydrate3 days of 0.1g/kg of body mass of sodium citrate and 4th day at 0.3 g/kg of body mass of sodium citrate in 500 milliliters of flavoured water |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 13-17
- Male
- Regional, provincial and national level swimmers
Key exclusion criteria (5 listed)
- Females
- Level of swimming below regional level standards
- Caffeine before trials
- Chronic health concerns
- Health problems before or during the course of the trial
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 Citrate DihydrateAlso: CAS: 6132-04-3Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic) | Other | Flavoured water placebo chronic dosing, Flavoured water placebo for acute dosing, Sodium Citrate Dihydrate Acute, Sodium Citrate Dihydrate Chronic |
Primary outcome
Time
Time frame: once each 200m performance
time to complete 200 metre swimming performances in seconds Participants chose type of swim stroke to swim a maximal effort 200 metre performance
1 secondary outcome
Lactate
Time frame: 3 min post performance
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24944546Russell C, Papadopoulos E, Mezil Y, Wells GD, Plyley MJ, Greenway M, Klentrou P. Acute versus chronic supplementation of sodium citrate on 200 m performance in adolescent swimmers. J Int Soc Sports Nutr. 2014 Jun 12;11:26. doi: 10.1186/1550-2783-11-26. eCollection 2014.
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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.
Nota Klentrou, PhD study director
Brock University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sodium Citrate Dihydrate in people with Alkalosis, run by Brock University 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 24 Jul 2014. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time (time frame: once each 200m performance). 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 NCT01835912, which also lists 1 linked publication.
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 24 Jul 2014.