About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Vitamin D3
DrugThe non-CF bronchiectasis subjects with Vitamin D deficiency would be given 1000 IU and 2000 IU.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Change in St. George's Respiratory Questionnaire (SGRQ) score
Scores range from 0 to 100, with higher scores indicating more limitations.
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.
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).
Sponsors and contacts
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Queen Mary Hospital, Hong Kong
Lead sponsor
The University of Hong Kong
Sponsor institution