Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-03-09 @ 2:15 AM
Study NCT ID:
NCT02427594
Status:
COMPLETED
Last Update Posted:
2017-08-30
First Post:
2015-04-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acid-Base Compensation in Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D007674', 'term': 'Kidney Diseases'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017693', 'term': 'Sodium Bicarbonate'}, {'id': 'C077571', 'term': 'baking powder'}], 'ancestors': [{'id': 'D001639', 'term': 'Bicarbonates'}, {'id': 'D002254', 'term': 'Carbonates'}, {'id': 'D002255', 'term': 'Carbonic Acid'}, {'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-08-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-29', 'studyFirstSubmitDate': '2015-04-23', 'studyFirstSubmitQcDate': '2015-04-27', 'lastUpdatePostDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Differences in metabolomic profiles', 'timeFrame': 'Measured at the end of each week of intervention (i.e. one week apart) up to 3 weeks', 'description': 'Differences in metabolites will be evaluated comparing the end of the controlled feeding plus sodium bicarbonate period to the end of the controlled feeding plus table salt period.'}], 'primaryOutcomes': [{'measure': 'Change in ambulatory blood pressure', 'timeFrame': 'Measured at the end of each week of intervention (i.e. one week apart)', 'description': 'Change in mean 24 hour systolic and diastolic blood pressure comparing the end of the controlled feeding plus sodium bicarbonate period to the end of the controlled feeding plus table salt period.'}, {'measure': 'Change in urine net acid excretion', 'timeFrame': 'Urine net acid excretion will be measured at three timepoints over approximately 3 weeks (i.e. 2 weeks of intervention plus one week baseline data collection/run-in)', 'description': 'Change in urine net acid excretion comparing the end of the controlled feeding plus sodium bicarbonate period to the end of the controlled feeding plus table salt period.'}], 'secondaryOutcomes': [{'measure': 'Change in clinic blood pressure', 'timeFrame': 'Clinic blood pressure will be measured at multiple timepoints over approximately 3 weeks (i.e. 2 weeks of intervention plus one week baseline data collection/run-in)', 'description': 'Change in average of three readings of systolic and diastolic blood pressure will be evaluated comparing the end of the controlled feeding plus sodium bicarbonate period to the end of the controlled feeding plus table salt period.'}, {'measure': 'Change in plasma nitric oxide metabolites', 'timeFrame': 'Measured at the end of each week of intervention (i.e. one week apart) up to 3 weeks', 'description': 'Change in nitric oxide metabolites comparing the end of the controlled feeding plus sodium bicarbonate period to the end of the controlled feeding plus table salt period.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Kidney Diseases', 'Renal Insufficiency, Chronic', 'Dietary nonvolatile acid load', 'Blood pressure', 'Urine net acid excretion'], 'conditions': ['Chronic Kidney Disease']}, 'referencesModule': {'references': [{'pmid': '33810868', 'type': 'DERIVED', 'citation': 'Tyson CC, Luciano A, Modliszewski JL, Corcoran DL, Bain JR, Muehlbauer M, Ilkayeva O, Pourafshar S, Allen J, Bowman C, Gung J, Asplin JR, Pendergast J, Svetkey LP, Lin PH, Scialla JJ. Effect of Bicarbonate on Net Acid Excretion, Blood Pressure, and Metabolism in Patients With and Without CKD: The Acid Base Compensation in CKD Study. Am J Kidney Dis. 2021 Jul;78(1):38-47. doi: 10.1053/j.ajkd.2020.10.015. Epub 2021 Mar 31.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate changes in urine net acid excretion, blood pressure and body chemistry that occur when the dietary acid load is lowered by using a drug/dietary supplement similar to baking soda. This may be important for patients with kidney disease because they may have difficulty removing all of the dietary acid load from the body in the urine. Participants with and without kidney disease will be recruited. Each participant will be fed a controlled diet for one week with sodium bicarbonate and for one week without sodium bicarbonate to evaluate these changes. The investigators will also determine if the effect of dietary acid load reduction is different in patients with kidney disease compared to those without kidney disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* estimated glomerular filtration rate ≥30 ml/min/1.73m2\n* serum bicarbonate 20-28 mEq/L\n\nExclusion Criteria:\n\n* diabetes mellitus\n* uncontrolled hypertension or recent (\\<3 weeks) titration of blood pressure medications\n* clinically significant volume overload on screening physical examination\n* selected medical conditions other than kidney disease and hypertension (active cancer, chronic liver failure, moderate to severe COPD, New York Heart Association class 2 or greater congestive heart failure, obstructive sleep apnea requiring nightly continuous positive airway pressure, solid organ transplant)\n* use of alkali supplementation\n* body mass index \\<18.5 or \\>40 kg/m2\n* ideal body weight \\<45.5 kg\n* anemia at screening (hematocrit \\<29% in participants with kidney disease or \\<33% in healthy participants)\n* pregnancy or breastfeeding\n* allergies, intolerance or unwillingness to consume foods or supplement provided in feeding menu\n* serum calcium less than 8.6 mg/dl on screening laboratories'}, 'identificationModule': {'nctId': 'NCT02427594', 'acronym': 'ABC', 'briefTitle': 'Acid-Base Compensation in Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Acid-Base Compensation in Chronic Kidney Disease: Measurement and Physiologic Impact', 'orgStudyIdInfo': {'id': 'Pro00058905'}, 'secondaryIdInfos': [{'id': 'K23DK095949', 'link': 'https://reporter.nih.gov/quickSearch/K23DK095949', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Controlled diet first', 'description': 'In this arm participants will first consume a controlled diet plus added table salt (sodium chloride) for one week. They will then consume an identical controlled diet plus sodium bicarbonate for one week. Sodium bicarbonate will be dosed as 2,600 mg divided three times daily if ideal body weight is \\<70 kg or 3,250 mg divided three times daily if ideal body weight is ≥70 kg. Added table salt will match the sodium content of the sodium bicarbonate dose (i.e. 31 or 39 mEq/day).', 'interventionNames': ['Drug: Sodium bicarbonate', 'Other: Controlled diet']}, {'type': 'EXPERIMENTAL', 'label': 'Sodium bicarbonate first', 'description': 'In this arm participants will first consume a controlled diet plus sodium bicarbonate for one week. They will then consume an identical controlled diet plus added table salt (sodium chloride) for one week. Sodium bicarbonate will be dosed as 2,600 mg divided three times daily if ideal body weight is \\<70 kg or 3,250 mg divided three times daily if ideal body weight is ≥70 kg. Added table salt will match the sodium content of the sodium bicarbonate dose (i.e. 31 or 39 mEq/day).', 'interventionNames': ['Drug: Sodium bicarbonate', 'Other: Controlled diet']}], 'interventions': [{'name': 'Sodium bicarbonate', 'type': 'DRUG', 'otherNames': ['Baking powder'], 'description': 'Drug/dietary supplement is used in a crossover design to lower the nonvolatile acid load of the diet compared to the control period.', 'armGroupLabels': ['Controlled diet first', 'Sodium bicarbonate first']}, {'name': 'Controlled diet', 'type': 'OTHER', 'description': 'Diet without sodium bicarbonate supplementation', 'armGroupLabels': ['Controlled diet first', 'Sodium bicarbonate first']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University School of Medicine', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Julia Scialla', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}