Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
Study NCT ID:
NCT00249951
Status:
COMPLETED
Last Update Posted:
2012-07-03
First Post:
2005-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Alkaline Citrate Treatment to Lower the Risk of Nephrocalcinosis in Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009397', 'term': 'Nephrocalcinosis'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'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': 'D002114', 'term': 'Calcinosis'}, {'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-29', 'studyFirstSubmitDate': '2005-11-03', 'studyFirstSubmitQcDate': '2005-11-03', 'lastUpdatePostDateStruct': {'date': '2012-07-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevention of nephrocalcinosis', 'timeFrame': 'First eight weeks of life', 'description': 'Prevention of the development of nephrocalcinosis under prophylactic treatment with an alkaline citrate prepration.'}], 'secondaryOutcomes': [{'measure': 'Increase in urinary citrate excretion', 'timeFrame': 'First eight weeks of life', 'description': 'Increase in urinary citrate excretion under prophylactic treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['nephrocalcinosis', 'premature infants', 'hypocitraturia', 'alcaline citrate therapy', 'Nephrocalcinosis in premature infants'], 'conditions': ['Nephrocalcinosis']}, 'referencesModule': {'references': [{'pmid': '12753307', 'type': 'BACKGROUND', 'citation': 'Sikora P, Roth B, Kribs A, Michalk DV, Hesse A, Hoppe B. Hypocitraturia is one of the major risk factors for nephrocalcinosis in very low birth weight (VLBW) infants. Kidney Int. 2003 Jun;63(6):2194-9. doi: 10.1046/j.1523-1755.2003.t01-4-00001.x.'}, {'pmid': '11956879', 'type': 'BACKGROUND', 'citation': 'Hoppe B, Duran I, Martin A, Kribs A, Benz-Bohm G, Michalk DV, Roth B. Nephrocalcinosis in preterm infants: a single center experience. Pediatr Nephrol. 2002 Apr;17(4):264-8. doi: 10.1007/s00467-001-0816-8.'}, {'pmid': '9779963', 'type': 'BACKGROUND', 'citation': 'Hoppe B, Roth B, Bauerfeld C, Langman CB. Oxalate, citrate, and sulfate concentration in human milk compared with formula preparations: influence on urinary anion excretion. J Pediatr Gastroenterol Nutr. 1998 Oct;27(4):383-6. doi: 10.1097/00005176-199810000-00002.'}, {'pmid': '8215570', 'type': 'BACKGROUND', 'citation': 'Hoppe B, Hesse A, Neuhaus T, Fanconi S, Forster I, Blau N, Leumann E. Urinary saturation and nephrocalcinosis in preterm infants: effect of parenteral nutrition. Arch Dis Child. 1993 Sep;69(3 Spec No):299-303. doi: 10.1136/adc.69.3_spec_no.299.'}]}, 'descriptionModule': {'briefSummary': "Preterm infants are at risk to develop nephrocalcinosis. Incidence numbers vary according to birth weight and gestation age. Very low birth weight infants have the highest risk index, with \\~ 7-10 % of preterm infants developing nephrocalcinosis in the patient population. We, the researchers at the University of Cologne, and others found significantly decreased urinary citrate excretion (hypocitraturia) to be one of the main risk factors. Hence, we hypothesized, that prophylactic treatment with oral alkaline citrate solution (Shol's solution) would help to 1) increase urinary citrate excretion and 2) help to decrease the incidence of nephrocalcinosis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Weeks', 'minimumAge': '5 Days', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Preterm infants \\< 32 weeks gestation age and \\< 1500 g birth weight\n\nExclusion Criteria:\n\n* Cardial, renal or gastrointestinal malformations\n* Chronic renal failure\n* Therapy with vitamin B6\n* High dose treatment with furosemide or dexamethasone\n* Addison's disease\n* Severe metabolic alkalosis\n* Worse clinical condition of preterm infant, which makes oral feeding impossible\n* Participation in other studies"}, 'identificationModule': {'nctId': 'NCT00249951', 'briefTitle': 'Alkaline Citrate Treatment to Lower the Risk of Nephrocalcinosis in Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'University of Cologne'}, 'orgStudyIdInfo': {'id': 'FG03-157'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Alkaline citrate', 'type': 'DRUG', 'otherNames': ["no brand names, Shol's solution versus placebo solution (NaCl 0.9 %)"], 'description': 'Prophylactic alkaline citrate medication during the first 8 weeks of life versus placebo solution to prevent nephrocalcinosis of prematurity.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-50924', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Prof. Dr. Bernd Hoppe', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}], 'overallOfficials': [{'name': 'Bernd Hoppe, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "University Children's Hospital Cologne, Kerpenerstr. 62, D-50924 Cologne, Germany"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cologne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head, Division of Pediatric Nephrology', 'investigatorFullName': 'Prof. Dr. B. Hoppe', 'investigatorAffiliation': 'University of Cologne'}}}}