[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558455":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":24,"studyPopulation":24,"armGroups":32,"interventions":43,"overallOfficials":24,"centralContacts":49,"locations":55,"responsibleParty":69,"collaborators":24,"id":74,"slug":24,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":24,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":24,"enrollmentInfo":82,"targetDuration":24,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":24,"overallStatus":58,"whyStopped":24,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Queen Mary Hospital, Hong Kong","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":24},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of patients who develop hospitalized bronchiectasis exacerbation","The proportion of patients who develop hospitalized bronchiectasis exacerbation during the follow-up period of 12 months, when compared with the 1-year period before.","From 1-year period before baseline to 12 months",[14,18,21],{"measure":15,"description":16,"timeFrame":17},"Change in St. George's Respiratory Questionnaire (SGRQ) score","Scores range from 0 to 100, with higher scores indicating more limitations.","From baseline to 6 and 12 months.",{"measure":19,"description":20,"timeFrame":17},"Change in bronchiectasis impact measure (BIM) score","A score ranges from 0 to 10 for each of eight domains consists of cough, sputum, breathlessness, tiredness, activity, general health, control, and exacerbation, with 10 being most severe.",{"measure":22,"description":23,"timeFrame":17},"Change in Bronchiectasis Health Questionnaire (BHQ) score","The instrument comprises 10 questions, each scored on a 7-point scale, to assess quality of life related to bronchiectasis on individuals for a recall period of 2 weeks. The total score ranges from 10 to 70, with a lower score indicating a more negative impact on health-related quality of life (HRQOL).",null,{"allocation":26,"interventionModel":27,"interventionModelDescription":28,"primaryPurpose":29,"observationalModel":24,"timePerspective":24,"maskingInfo":30},"NON_RANDOMIZED","PARALLEL","104 subjects will be separated into two groups according to their Baseline blood 25-hydroxyvitamin-D level: vitamin D deficient (below 50 nmol\u002FL) and vitamin D non-deficient (at or above 50 nmol\u002FL). There were initially 42 and 62 patients in the vitamin D deficient and vitamin D non-deficient groups respectively.","PREVENTION",{"masking":31,"maskingDescription":24,"whoMasked":24},"NONE",[33,39],{"label":34,"type":35,"description":36,"interventionNames":37},"Vitamin D replacement","ACTIVE_COMPARATOR","Those with vitamin D deficiency will be replaced with vitamin D3 at 1000 IU at the first visit. Vitamin D3 1000 IU is expected to increase blood 25-hydroxyvitamin-D level by 25 nmol\u002FL. Blood 25-hydroxyvitamin-D level will be rechecked 3 months after replacement. If the blood 25-hydroxyvitamin-D level is still below 50 nmol\u002FL, the vitamin D3 replacement dosage will be increased to 2000 IU.",[38],"Drug: Vitamin D3",{"label":40,"type":41,"description":42,"interventionNames":24},"Vitamin D non-deficiency","NO_INTERVENTION","No drug will be given to patients with Vitamin D non-deficiency.",[44],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":24},"DRUG","Vitamin D3","The non-CF bronchiectasis subjects with Vitamin D deficiency would be given 1000 IU and 2000 IU.",[34],[50],{"name":51,"role":52,"phone":53,"phoneExt":24,"email":54},"Wang Chun Kwok, MBBS","CONTACT","2255 3111","kwokwch@hku.hk",[56],{"facility":57,"status":58,"city":59,"state":24,"zip":24,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Queen Mary Hospital","RECRUITING","Hong Kong","HK",{"type":62,"coordinates":63},"Point",[64,65],114.17469,22.27832,{"lat":65,"lon":64},[68],{"name":51,"role":52,"phone":24,"phoneExt":24,"email":24},{"type":70,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":73,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Kwok Wang Chun","Clinical Assistant Professor","The University of Hong Kong","100558455",false,"NCT06551337","Vitamin D Replacement in Bronchiectasis","Prospective Clinical Study on Vitamin D Replacement in Bronchiectasis - A Pilot Study","Inclusion Criteria:\n\n1. ages 18 years or above, male or female.\n2. confirmed diagnosis of non-CF bronchiectasis based on high-resolution computed tomography (HRCT) scan.\n3. participation in the prior study entitled \"Prospective clinical study on serum 25-hydroxyvitamin D (25-OH D) level and risk of bronchiectasis exacerbation\" (UW 22-317)\n\nExclusion Criteria:\n\n1. underlying asthma, COPD and other co-existing respiratory diseases\n2. underlying osteoporosis\n3. supplementary Vitamin D in their regimen\n4. advanced chronic kidney disease with estimated glomerular filtration rate (eGFR) \\\u003C 30mL\u002Fmin","ALL","18 Years",{"count":83,"type":84},104,"ESTIMATED","INTERVENTIONAL",[87],"PHASE4","This study seeks to address the limitations in previous related studies on vitamin D replacement and bronchiectasis exacerbation occurrence through a self-controlled pilot study. The investigators aim to investigate whether vitamin D replacement in bronchiectasis patients with vitamin D deficiency can reduce hospitalized bronchiectasis exacerbation occurrence. Patients who participated in the prior study entitled \"Prospective clinical study on serum 25-hydroxyvitamin D (25-OH D) level and risk of bronchiectasis exacerbation\" (UW 22-317) will be invited for participation during regular clinic follow-up and management in Queen Mary Hospital. If participants are willing to join the further research, participants will be recruited in this self-controlled study. There are some differences from usual management to non-CF bronchiectasis subjects. The study subjects would be checked for their blood 25-hydroxyvitamin-D level during the study period. The non-CF bronchiectasis subjects with Vitamin D deficiency would be given 1000 IU and 2000 IU (if needed). The investigators aim to correct their Vitamin D deficiency completely, aiming at blood 25-hydroxyvitamin-D level \\>=50, i.e. treat to target. The dose depends on the level of Vitamin D after replacement. If blood 25-hydroxyvitamin-D level is 50 or above, then 1000 IU is suffice. If blood 25-hydroxyvitamin-D level is still below 50, the investigators will increase to 2000 IU.",[90],"Bronchiectasis","2024-08-09",{"date":93,"type":94},"2024-08-13","ACTUAL",{"date":96,"type":94},"2024-04-17",{"date":98,"type":84},"2027-06-30",{"name":5,"class":6},1]