Vitamin D as an Adjunctive Treatment in Patients With Non-Cystic Fibrosis Bronchiectasis (VIDB)
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02507843
|Contact: JinFu Xufirstname.lastname@example.org|
|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|