Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2026-02-24 @ 3:14 PM
Study NCT ID:
NCT03249012
Status:
RECRUITING
Last Update Posted:
2024-08-28
First Post:
2017-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life Related to Different Treatment Protocols for Post-thyroidectomy Hypoparathyroidism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002117', 'term': 'Calcitriol'}], 'ancestors': [{'id': 'D004100', 'term': 'Dihydroxycholecalciferols'}, {'id': 'D006887', 'term': 'Hydroxycholecalciferols'}, {'id': 'D002762', 'term': 'Cholecalciferol'}, {'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-26', 'studyFirstSubmitDate': '2017-08-09', 'studyFirstSubmitQcDate': '2017-08-10', 'lastUpdatePostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline quality of life at 1 and 4 weeks', 'timeFrame': 'Pre-op, 1 week post-op and 4 weeks post-op', 'description': 'Short Form 36 (SF-36) questionnaire'}], 'secondaryOutcomes': [{'measure': 'Occurence and change in pharmacologic adverse effects of calcium carbonate and calcitriol', 'timeFrame': '1 week post-op, 4 weeks post-op', 'description': 'A questionnaire about the adverse effects of calcium carbonate and calcitriol will be completed at post-op week 1 and 4'}, {'measure': 'Occurence and change in symptoms of hypocalcemia', 'timeFrame': '1 week post-op, 4 weeks post-op', 'description': 'A questionnaire about symptoms of hypocalcemia will be completed at post-op week 1 and 4.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypoparathyroidism Postprocedural', 'Quality of Life']}, 'descriptionModule': {'briefSummary': 'This study aims to compare two different protocols commonly used in the management of post thyroidectomy hypoparathyroidism : PTH based calcium repletion and empiric repletion. The investigators aim to compare the quality of life associated with these two protocols in a randomized trial.', 'detailedDescription': 'Enrolled patients will be randomized in two treatment groups. In group 1, all patients will receive calcium carbonate and calcitriol in the post-operative period, with standardized weaning. In group 2, patients will be prescribed calcium carbonate and calcitriol only if their post-operative PTH dosage is 25% or less of the pre-operative dosage, or if post-operative PTH is inferior to 15.\n\nThe Short-Form 36 (SF-36) questionnaire (French canadian version) will be used to assess quality of life pre-operatively and at post-op week 1 and 4. Symptoms of hypocalcemia and adverse effects of calcium carbonate and calcitriol will be monitored at week 1 and 4.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Total thyroidectomy or completion hemithyroidectomy\n\nExclusion Criteria:\n\n* Need for neck dissection\n* Unable to fill in questionnaires (intellectual deficit, severe psychiatric disorder, illiterate, does not speak French or English)'}, 'identificationModule': {'nctId': 'NCT03249012', 'briefTitle': 'Quality of Life Related to Different Treatment Protocols for Post-thyroidectomy Hypoparathyroidism', 'organization': {'class': 'OTHER', 'fullName': 'CHU de Quebec-Universite Laval'}, 'officialTitle': 'Comparing the Quality of Life Associated With Empiric Calcium Repletion and Parathormone (PTH) Based Calcium Repletion for Post Thyroidectomy Hypoparathyroidism', 'orgStudyIdInfo': {'id': '2018-3422'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Empiric calcium and calcitriol repletion group', 'description': 'All patients in this group will receive post-operative calcium carbonate and calcitriol.', 'interventionNames': ['Other: Empiric use of Calcium Carbonate and Calcitriol']}, {'type': 'EXPERIMENTAL', 'label': 'PTH based repletion group', 'description': 'Patients in this group will be prescribed calcium carbonate and calcitriol based on their post-operative PTH.', 'interventionNames': ['Other: PTH based Calcium Carbonate and Calcitriol repletion']}], 'interventions': [{'name': 'Empiric use of Calcium Carbonate and Calcitriol', 'type': 'OTHER', 'description': 'Empiric calcium carbonate and calcitriol repletion', 'armGroupLabels': ['Empiric calcium and calcitriol repletion group']}, {'name': 'PTH based Calcium Carbonate and Calcitriol repletion', 'type': 'OTHER', 'description': 'PTH based treatment', 'armGroupLabels': ['PTH based repletion group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1J1Z4', 'city': 'Québec', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Jean-Philippe Vezina, MD', 'role': 'CONTACT', 'email': 'jean-philippe.vezina@fmed.ulaval.ca', 'phone': '418-649-0252'}], 'facility': 'CHU de Quebec', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'centralContacts': [{'name': 'Jean-Philippe Vezina, MD, FRCSC', 'role': 'CONTACT', 'email': 'jean-philippe.vezina@fmed.ulaval.ca', 'phone': '418-649-0252'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHU de Quebec-Universite Laval', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Otolaryngologist and Head & Neck Surgeon', 'investigatorFullName': 'Jean-Philippe Vézina', 'investigatorAffiliation': 'CHU de Quebec-Universite Laval'}}}}