Prospective Clinical Study on Vitamin D Replacement in Bronchiectasis - A Pilot Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- Proportion of patients who develop hospitalized bronchiectasis exacerbation
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ages 18 years or above, male or female.
- •confirmed diagnosis of non-CF bronchiectasis based on high-resolution computed tomography (HRCT) scan.
- •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)
Exclusion Criteria
- •underlying asthma, COPD and other co-existing respiratory diseases
- •underlying osteoporosis
- •supplementary Vitamin D in their regimen
- •advanced chronic kidney disease with estimated glomerular filtration rate (eGFR) < 30mL/min
Arms & Interventions
Vitamin D replacement
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/L. Blood 25-hydroxyvitamin-D level will be rechecked 3 months after replacement. If the blood 25-hydroxyvitamin-D level is still below 50 nmol/L, the vitamin D3 replacement dosage will be increased to 2000 IU.
Intervention: Vitamin D3 (Drug)
Outcomes
Primary Outcomes
Proportion of patients who develop hospitalized bronchiectasis exacerbation
Time Frame: From 1-year period before baseline to 12 months
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.
Secondary Outcomes
- Change in bronchiectasis impact measure (BIM) score(From baseline to 6 and 12 months.)
- Change in St. George's Respiratory Questionnaire (SGRQ) score(From baseline to 6 and 12 months.)
- Change in Bronchiectasis Health Questionnaire (BHQ) score(From baseline to 6 and 12 months.)
Investigators
Kwok Wang Chun
Clinical Assistant Professor
The University of Hong Kong