Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT03951558
Status:
UNKNOWN
Last Update Posted:
2019-05-15
First Post:
2019-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of the Impact of Diet vs Thiazide in BMD in Children With Idiopathic Hypercalciuria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053565', 'term': 'Hypercalciuria'}, {'id': 'D053040', 'term': 'Nephrolithiasis'}], 'ancestors': [{'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004032', 'term': 'Diet'}, {'id': 'D006852', 'term': 'Hydrochlorothiazide'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D002740', 'term': 'Chlorothiazide'}, {'id': 'D001581', 'term': 'Benzothiadiazines'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D049971', 'term': 'Thiazides'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'The capsules are the same color in the placebo group and the intervention group. The content of the capsules is similar in both groups.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-14', 'studyFirstSubmitDate': '2019-05-10', 'studyFirstSubmitQcDate': '2019-05-14', 'lastUpdatePostDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bone mineral density', 'timeFrame': 'one year', 'description': 'bone mineral density will be evaluated by means of score z evaluated by dexa'}], 'secondaryOutcomes': [{'measure': 'Ca/Cr index', 'timeFrame': 'one year', 'description': 'urinary calcium excretion will be evaluated'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diet', 'drinking water', 'salt', 'dietaryprotein'], 'conditions': ['Hypercalciuria; Idiopathic', 'Nephrolithiasis']}, 'descriptionModule': {'briefSummary': "The investigator's objective is to compare and evaluate the impact of nutritional treatment vs. pharmacological treatment (hydrochlorothiazide) in bone mineral density in children with idiopathic hypercalciuria.\n\nA randomized, open-label, one-year follow-up study will be conducted in children aged 5 to 21 years with a confirmed diagnosis of idiopathic hypercalciuria or lithiasis, excluding those patients with secondary hypercalciuria (primary hyperoxaluria, treatment with vitamin D, Bartter syndrome, primary hyperparathyroidism), previous kidney transplantation. The impact of diet (hyposodic, calcium intake according to DIR for age, normal protein intake and high water intake) will be evaluated vs. the pharmacological treatment (hydrochlorothiazide) on bone mineral density.", 'detailedDescription': 'A randomized, open-label clinical trial will be conducted with a one-year follow-up. For which basal measurement of calciuria, citraturia, serum creatinine, serum and urinary electrolytes, parathyroid hormone, vitamin D levels and renal ultrasound, as well as dietary intake (protein, energy, salt and water). The dietary intake per day of food and pharmacological treatment will be evaluated quarterly, body composition (anthropometry) and serum and urinary electrolyte levels will be measured; Bone constitution (DXA, quantitative bone ultrasound), IL-1 (as inflammatory markers) and vitamin D will be evaluated every six months.\n\nParticipants will be blinded to the pharmacological treatment they will receive. The randomization of the participants will be done through the page www.randomization.com. The randomization was performed by blocks, where blocks of 6 members each were made i. Group 1: only recommendations of water intake and reduction of salt intake and hydrochlorothiazide will be given (the dose will be assigned according to weight and sex by a pediatric nephrologist, dose of 0.5-1.5mg / kg / day, starting with the dose 1 mg / kg). Hydrochlorothiazide will be provided to the patient.\n\nii. Group 2: placebo capsules and a strict diet plan will be given. The placebo will look similar to that of hydrochlorothiazide and will be prepared in the Nephrology Research Laboratory by Biol. Ana María Hernández Sánchez and Quim Lourdes Ortiz. The feeding plan will be appropriate for the patient, it will consist of:\n\n1. 40 ml / Kg / day of water\n2. Protein according to age and sex\n3. Recommendations for low sodium intake\n4. Calcium according to age and sex (minimum 800mg)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of idiopathic hypercalciuria\n* Man or women\n* 5 to 21 years\n\nExclusion Criteria:\n\n* Clinical diagnosis of secondary hypercalciuria (primary hyperoxaluria, treatment with vitamin D, Bartter syndrome, primary hyperparathyroidism)\n* Previous kidney transplant\n* Clinical diagnosis of kidney disease.\n* Vitamin D intake (more than 800 mg/day)'}, 'identificationModule': {'nctId': 'NCT03951558', 'acronym': 'HIC', 'briefTitle': 'Comparison of the Impact of Diet vs Thiazide in BMD in Children With Idiopathic Hypercalciuria', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Infantil de Mexico Federico Gomez'}, 'officialTitle': 'Comparison of the Impact of Nutritional Treatment vs Hydrochlorothiazide on Bone Mineral Density and Body Composition in Children With Idiopathic Hypercalciuria of the Hospital Infantil de Méxio Federico Gómez', 'orgStudyIdInfo': {'id': 'HIM-2017-046'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diet for calciuria prevention', 'description': 'placebo capsules and a strict eating plan will be given. The placebo will look similar to that of hydrochlorothiazide and will be prepared in the Nephrology Research Laboratory by Biol. Ana María Hernández Sánchez and Quim Lourdes Ortiz.', 'interventionNames': ['Other: Diet for calciuria prevention']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'hydrochlorothiazide for calciuria prevention', 'description': 'recommendations for water intake and decrease in salt intake will be given.', 'interventionNames': ['Drug: Hydrochlorothiazide']}], 'interventions': [{'name': 'Diet for calciuria prevention', 'type': 'OTHER', 'otherNames': ['Diet for hypercalciuria'], 'description': 'Dietary recommendations for water, salt, calcium and proteins according to age and DIR', 'armGroupLabels': ['Diet for calciuria prevention']}, {'name': 'Hydrochlorothiazide', 'type': 'DRUG', 'otherNames': ['Hydroclorothiazide in hypercalciuria'], 'description': 'Hydroclorothiazide recommendations for hypercalciuria', 'armGroupLabels': ['hydrochlorothiazide for calciuria prevention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06720', 'city': 'México', 'state': 'México City', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Ma Elena Ortiz Cornejo, Master', 'role': 'CONTACT', 'email': 'meocnutricion@gmail.com', 'phone': '(52) 01 55 5228 9917', 'phoneExt': '4410'}, {'name': 'Mara Medeiros Domingo, PhD', 'role': 'CONTACT', 'phone': '(52) 01 55 5228 9917', 'phoneExt': '4410'}], 'facility': "Children's Hospital of Mexico, Federico Gómez", 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}], 'centralContacts': [{'name': 'Ma Elena Ortiz Cornejo, Master', 'role': 'CONTACT', 'email': 'meocnutricion@gmail.com', 'phone': '(52) 01 55 5228 9917', 'phoneExt': '4410'}, {'name': 'Mara Medeiros Domingo, PhD', 'role': 'CONTACT', 'phone': '(52) 01 55 5228 9917', 'phoneExt': '4410'}], 'overallOfficials': [{'name': 'Elena Ortiz, Master', 'role': 'STUDY_CHAIR', 'affiliation': 'Laboratorio de Enseñanza Virtual y Ciberpsicología. Facultad de Psicología. UNAM'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'will be available at within one year', 'ipdSharing': 'YES', 'description': 'a report of results will be made by means of a research article and information will be provided that researchers interested in the obtained data request', 'accessCriteria': 'Requests for additional information will be reviewed by Nutriologa Ma Elena Ortiz and PhD. Mara Medeiros Domingo'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Infantil de Mexico Federico Gomez', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph D Mara Medeiros Domingo', 'investigatorFullName': 'Mara Medeiros', 'investigatorAffiliation': 'Hospital Infantil de Mexico Federico Gomez'}}}}