Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-03-03 @ 2:21 AM
Study NCT ID:
NCT00509405
Status:
COMPLETED
Last Update Posted:
2012-04-24
First Post:
2007-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Neutralization of Endogenous Acid Production on BMD and Bone Microarchitectural
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000138', 'term': 'Acidosis'}, {'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D055948', 'term': 'Sarcopenia'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019357', 'term': 'Potassium 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 202}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-23', 'studyFirstSubmitDate': '2007-07-30', 'studyFirstSubmitQcDate': '2007-07-30', 'lastUpdatePostDateStruct': {'date': '2012-04-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BMD at L2-L4 by DEXA and microarchitectural composition of bone in both tibias and radius', 'timeFrame': '12 and 24 months'}], 'secondaryOutcomes': [{'measure': 'Effect on BMD at hip and total body Effect on 24h ambulatory blood pressure', 'timeFrame': '12 and 24 months'}, {'measure': 'effect on skeletal muscle mass and strength', 'timeFrame': '12 and 24 months'}, {'measure': 'effect on left ventricular muscle mass', 'timeFrame': '24 months'}, {'measure': 'effect on carotid media-intima thickness', 'timeFrame': '24 months'}, {'measure': 'Hypoxia-induced endothelial vasorelaxation', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Endogenous acid production', 'metabolic acidosis', 'potassium citrate', 'osteoporosis', 'sarcopenia', 'hypertension', 'Effect of potassium citrate on bone mineral density and bone mass'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.medicalforum.ch', 'label': 'check in archive for "essen wir zu sauer"'}]}, 'descriptionModule': {'briefSummary': 'Hypothesis: Neutralization of acid production induced by the Western diet with oral administration of potassium citrate increases bone mineral density and bone mass as well as skeletal muscle mass and strength in elderly people (\\> 65y).', 'detailedDescription': 'We will perform a prospective, randomized, placebo-controlled trial evaluating the effect of K citrate on bone mineral density, microarchitectural composition of bone,nutritional parameters, lean body mass, parameters of skeletal muscle mass and strength, 24h and exercise induced blood pressure changes in otherwise healthy, elderly ambulatory subjects of both genders.\n\nPotassium citrate (60 mEq) is supplied as tablets with a wax matrix (10 mEq of citrate per tablet) and ingested in three doses/day. All subjects will receive daily oral 500 mg of calcium and 400 IU of vitamin D to ensure adequate calcium and vitamin D supply.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women, 65 to 80y, tscores at L2-L4 0 to -2.5\n\nExclusion Criteria:\n\n* Treated or necessity to treat low BMD (t-score L2 to L4 \\<-2.5)\n* Any major medical illness that would possibly need hospitalization and/or be followed by foreseeable complications within 12 months and/or have a life-expectancy of less than 5 years\n* Stable serum creatinine \\> 150 umol/l and/or known Type IV renal-tubular acidosis (hyperkalemia)\n* vegetarians\n* concommitant drug prescriptions: systemic and topical glucocorticoids, systemically acting estrogens (topical allowed): both within the last 6 months. antiosteoporosis drugs: bisphosphoponates, fluoride, calcitonin, all within the previous 12 months.\n* vitamin D deficiency at screening visit\n* technical difficulties to delineate bone area of interest during the screening visit'}, 'identificationModule': {'nctId': 'NCT00509405', 'briefTitle': 'Effect of Neutralization of Endogenous Acid Production on BMD and Bone Microarchitectural', 'organization': {'class': 'OTHER', 'fullName': 'Kantonsspital Baselland Bruderholz'}, 'officialTitle': 'Effect of Neutralization of Endogenous Acid Production on Bone Mineral Density and Microarchitectural Composition of Bone in Humans', 'orgStudyIdInfo': {'id': '316/06'}, 'secondaryIdInfos': [{'id': 'NFP 53: 4053-110259'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Potassium citrate', 'interventionNames': ['Drug: potassium citrate']}], 'interventions': [{'name': 'potassium citrate', 'type': 'DRUG', 'description': '6 times 10 mEq per day, oral for 24 months', 'armGroupLabels': ['Potassium citrate']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CH-4101', 'city': 'Bruderholz/Basel', 'state': 'Basel-Landschaft', 'country': 'Switzerland', 'facility': 'Department of Medicine, Kantonsspital Bruderholz'}], 'overallOfficials': [{'name': 'Reto Krapf, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Medicine, Kantonsspital Bruderholz, CH-4101 Bruderholz/Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kantonsspital Baselland Bruderholz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Reto Krapf', 'investigatorAffiliation': 'Kantonsspital Baselland Bruderholz'}}}}