Vitamin D Replacement in Bronchiectasis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vitamin D3.
- Who it may be relevant to
- Registry conditions: Bronchiectasis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Clinical Study on Vitamin D Replacement in Bronchiectasis - A Pilot Study
Overview
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.
Interventions
- Drug Vitamin D3
The non-CF bronchiectasis subjects with Vitamin D deficiency would be given 1000 IU and 2000 IU.
Primary outcome measures
- Proportion of patients who develop hospitalized bronchiectasis exacerbation [Time frame: From 1-year period before baseline to 12 months]
Secondary outcome measures (3)
- Change in St. George's Respiratory Questionnaire (SGRQ) score [Time frame: From baseline to 6 and 12 months.]
- Change in bronchiectasis impact measure (BIM) score [Time frame: From baseline to 6 and 12 months.]
- Change in Bronchiectasis Health Questionnaire (BHQ) score [Time frame: From baseline to 6 and 12 months.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Hong Kong · 1 center
- Queen Mary Hospital — Hong Kong
Identifiers
NCT: NCT06551337 · UW 24-205