Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-03-26 @ 2:42 PM
Study NCT ID:
NCT01835912
Status:
COMPLETED
Last Update Posted:
2014-07-24
First Post:
2013-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Chronic Versus Acute Dosing of Sodium Citrate for Swimming 200m
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000471', 'term': 'Alkalosis'}], 'ancestors': [{'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077559', 'term': 'Sodium Citrate'}], 'ancestors': [{'id': 'D019343', 'term': 'Citric Acid'}, {'id': 'D002951', 'term': 'Citrates'}, {'id': 'D014233', 'term': 'Tricarboxylic Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nklentrou@brocku.ca', 'phone': '19056885550', 'title': 'Panagiota Klentrou', 'phoneExt': '4538', 'organization': 'BrockU'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Flavoured Water Placebo for Acute Dosing', 'description': '500 milliliters flavoured water (placebo for the acute dosing intervention of sodium citrate)', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sodium Citrate Dihydrate Acute', 'description': 'dose: 0.5 g/kg of body mass dissolved in 500 milliliters of flavoured water\n\nSodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Flavoured Water Placebo for Chronic Dosing', 'description': '500 milliliters flavoured water (placebo for the chronic dosing intervention of sodium citrate)', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Sodium Citrate Dihydrate Chronic', 'description': '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\n\nSodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Flavoured Water Placebo for Acute Dosing', 'description': '500 milliliters flavoured water (placebo for the acute dosing intervention of sodium citrate)'}, {'id': 'OG001', 'title': 'Sodium Citrate Dihydrate Acute', 'description': 'dose: 0.5 g/kg of body mass dissolved in 500 milliliters of flavoured water\n\nSodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)'}, {'id': 'OG002', 'title': 'Flavoured Water Placebo for Chronic Dosing', 'description': '500 milliliters flavoured water (placebo for the chronic dosing intervention of sodium citrate)'}, {'id': 'OG003', 'title': 'Sodium Citrate Dihydrate Chronic', 'description': '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\n\nSodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)'}], 'classes': [{'categories': [{'measurements': [{'value': '144.2', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '145.3', 'spread': '5.3', 'groupId': 'OG001'}, {'value': '145.3', 'spread': '5.4', 'groupId': 'OG002'}, {'value': '144.8', 'spread': '5.3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'once each 200m performance', 'description': 'time to complete 200 metre swimming performances in seconds\n\nParticipants chose type of swim stroke to swim a maximal effort 200 metre performance', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lactate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Flavoured Water Placebo for Acute Dosing', 'description': '500 milliliters flavoured water (placebo for the acute dosing intervention of sodium citrate)'}, {'id': 'OG001', 'title': 'Sodium Citrate Dihydrate Acute', 'description': 'dose: 0.5 g/kg of body mass dissolved in 500 milliliters of flavoured water\n\nSodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)'}, {'id': 'OG002', 'title': 'Flavoured Water Placebo for Chronic Dosing', 'description': '500 milliliters flavoured water (placebo for the chronic dosing intervention of sodium citrate)'}, {'id': 'OG003', 'title': 'Sodium Citrate Dihydrate Chronic', 'description': '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\n\nSodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)'}], 'classes': [{'categories': [{'measurements': [{'value': '8.8', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '10.4', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '9.5', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '10.8', 'spread': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 min post performance', 'description': 'lactate measured at 3min post trial', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of Perceived Exertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Flavoured Water Placebo for Acute Dosing', 'description': '500 milliliters flavoured water (placebo for the acute dosing intervention of sodium citrate)'}, {'id': 'OG001', 'title': 'Sodium Citrate Dihydrate Acute', 'description': 'dose: 0.5 g/kg of body mass dissolved in 500 milliliters of flavoured water\n\nSodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)'}, {'id': 'OG002', 'title': 'Flavoured Water Placebo for Chronic Dosing', 'description': '500 milliliters flavoured water (placebo for the chronic dosing intervention of sodium citrate)'}, {'id': 'OG003', 'title': 'Sodium Citrate Dihydrate Chronic', 'description': '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\n\nSodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)'}], 'classes': [{'categories': [{'measurements': [{'value': '16.4', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '16.1', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '16.6', 'spread': '0.3', 'groupId': 'OG002'}, {'value': '17.1', 'spread': '0.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Rate of Perceived Exertion after each 200m swimming performance', 'description': 'Rate of perceived exertion (RPE) was recorded after each 200 metre swimming performance\n\nRPE scale is from 6-20. Minimum = 6 (level of exertion equal to lying down) and Maximum = 20 (maximal perceived exertion)\n\nNumbers reported are the average of the RPE recorded for all 10 participants.', 'unitOfMeasure': 'units on a scale (6-20)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Study Participants', 'description': 'Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic) and their corresponding placebos.\n\n4 arms: Acute, Acute Placebo, Chronic, Chronic Placebo\n\nAcute: 0.5 g/kg of body mass of sodium citrate in 500 millilitres of flavoured water\n\nAcute Placebo: 500 milliliters of flavoured water\n\nChronic: 3 days of 0.1 g/kg of body mass of sodium citrate and 4th day at 0.3 g/kg of body mass of sodium citrate in 500 millilitres of flavoured water\n\nChronic Placebo: 3 days of 500 millilitres of flavoured water and 4th day 500 millilitres of flavoured water'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Acute', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Acute Placebo', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Chronic', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Chronic Placebo', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'Acute: dose: 0.5 g/kg of body mass dissolved in 500 milliliters of flavoured water\n\nSodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)\n\nAcute Placebo: 500 milliliters flavoured water (placebo for the acute dosing intervention of sodium citrate)\n\nChronic: 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\n\nSodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)\n\nChronic Placebo: 3 days of 500 milliliters flavoured water and the 4th day 500 milliliters flavoured water (placebo for the chronic dosing intervention of sodium citrate)'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'males', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-23', 'studyFirstSubmitDate': '2013-04-10', 'resultsFirstSubmitDate': '2014-03-19', 'studyFirstSubmitQcDate': '2013-04-18', 'lastUpdatePostDateStruct': {'date': '2014-07-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-07-23', 'studyFirstPostDateStruct': {'date': '2013-04-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Rate of Perceived Exertion', 'timeFrame': 'Rate of Perceived Exertion after each 200m swimming performance', 'description': 'Rate of perceived exertion (RPE) was recorded after each 200 metre swimming performance\n\nRPE scale is from 6-20. Minimum = 6 (level of exertion equal to lying down) and Maximum = 20 (maximal perceived exertion)\n\nNumbers reported are the average of the RPE recorded for all 10 participants.'}], 'primaryOutcomes': [{'measure': 'Time', 'timeFrame': 'once each 200m performance', 'description': 'time to complete 200 metre swimming performances in seconds\n\nParticipants chose type of swim stroke to swim a maximal effort 200 metre performance'}], 'secondaryOutcomes': [{'measure': 'Lactate', 'timeFrame': '3 min post performance', 'description': 'lactate measured at 3min post trial'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['performance', 'speed', 'exertion'], 'conditions': ['Alkalosis']}, 'referencesModule': {'references': [{'pmid': '24944546', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nIngestion 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.\n\nResearchers 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.\n\nThe investigators will test the null hypothesis that sodium citrate ingestion (chronic and acute) will not have an effect on exercise performance compared to placebo.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 13-17\n* Male\n* Regional, provincial and national level swimmers\n\nExclusion Criteria:\n\n* Females\n* Level of swimming below regional level standards\n* Caffeine before trials\n* Chronic health concerns\n* Health problems before or during the course of the trial'}, 'identificationModule': {'nctId': 'NCT01835912', 'briefTitle': 'Chronic Versus Acute Dosing of Sodium Citrate for Swimming 200m', 'organization': {'class': 'OTHER', 'fullName': 'Brock University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '12-009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Flavoured water placebo for acute dosing', 'description': '500 milliliters flavoured water (placebo for the acute dosing intervention of sodium citrate)', 'interventionNames': ['Other: Sodium Citrate Dihydrate']}, {'type': 'EXPERIMENTAL', 'label': 'Sodium Citrate Dihydrate Acute', 'description': 'dose: 0.5 g/kg of body mass dissolved in 500 milliliters of flavoured water', 'interventionNames': ['Other: Sodium Citrate Dihydrate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Flavoured water placebo chronic dosing', 'description': '500 milliliters flavoured water (placebo for the chronic dosing intervention of sodium citrate)', 'interventionNames': ['Other: Sodium Citrate Dihydrate']}, {'type': 'EXPERIMENTAL', 'label': 'Sodium Citrate Dihydrate Chronic', 'description': '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', 'interventionNames': ['Other: Sodium Citrate Dihydrate']}], 'interventions': [{'name': 'Sodium Citrate Dihydrate', 'type': 'OTHER', 'otherNames': ['CAS: 6132-04-3'], 'description': 'Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)', 'armGroupLabels': ['Flavoured water placebo chronic dosing', 'Flavoured water placebo for acute dosing', 'Sodium Citrate Dihydrate Acute', 'Sodium Citrate Dihydrate Chronic']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'l2s3a1', 'city': 'St. Catharines', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Brock University', 'geoPoint': {'lat': 43.17126, 'lon': -79.24267}}], 'overallOfficials': [{'name': 'Nota Klentrou, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Brock University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brock University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.Sc. Researcher Brock University', 'investigatorFullName': 'Colin Russell', 'investigatorAffiliation': 'Brock University'}}}}