Vitamin D as an Adjunctive Treatment in Patients With Non-Cystic Fibrosis Bronchiectasis (VIDB)
|ClinicalTrials.gov Identifier: NCT02507843|
Recruitment Status : Unknown
Verified July 2015 by Jin-Fu Xu, Shanghai Pulmonary Hospital, Shanghai, China.
Recruitment status was: Recruiting
First Posted : July 24, 2015
Last Update Posted : July 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Bronchiectasis||Drug: Cholecalciferol Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Vitamin D as an Adjunctive Treatment in Patients With Non-Cystic Fibrosis Bronchiectasis: a Double-blind Randomised Controlled Trial|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||June 2017|
Active Comparator: Vitamin D group
Cholecalciferol will be administered by monthly oral intake. During a prospective follow-up period of one year, the patients will get the normal care with some additional tests for the study.
Oral Cholecalciferol(100000 IU) will be administered in Vitamin D group monthly for 6 months.
Other Name: Vitamin D3
Placebo Comparator: Placebo group
Placebo will be administered by monthly oral intake. During a prospective follow-up period of one year, the patients will get the normal care with some additional tests for the study.
Placebo will be administered in placebo group monthly for 6 months.
Other Name: Migliol Placebo Oil
- Time to first acute exacerbation [ Time Frame: one year ]
- total number of exacerbations per group [ Time Frame: one year ]
- percentage of patients with one or more exacerbations per year [ Time Frame: one year ]
- severity of diseases [ Time Frame: one year ]FACED（FEV1% predicted, age, chronic colonization by Pseudomonas aeruginosa， radiological extent of the disease， and dyspnea） score
- using of antibiotics [ Time Frame: one year ]types of antibiotics used during exacerbations
- quality of life [ Time Frame: one year ]the Quality of Life-Bronchiectasis (QOL-B) questionnaire
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02507843
|Contact: JinFu Xuemail@example.com|
|Shanghai Pulmonary Hospital , Tongji University||Recruiting|
|Shanghai, Shanghai, China, 200000|
|Contact: Kei Fei +86-021-65115006|
|Principal Investigator:||JinFu Xu||Shanghai Pulmonary Hospital , Tongji University|