Bronchiectasis
Conditions
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.
Interventions
DRUGVitamin D3
The non-CF bronchiectasis subjects with Vitamin D deficiency would be given 1000 IU and 2000 IU.
Sponsors
Queen Mary Hospital, Hong Kong
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
104 subjects will be separated into two groups according to their Baseline blood 25-hydroxyvitamin-D level: vitamin D deficient (below 50 nmol/L) and vitamin D non-deficient (at or above 50 nmol/L). There were initially 42 and 62 patients in the vitamin D deficient and vitamin D non-deficient groups respectively.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ages 18 years or above, male or female. 2. confirmed diagnosis of non-CF bronchiectasis based on high-resolution computed tomography (HRCT) scan. 3. 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
1. underlying asthma, COPD and other co-existing respiratory diseases 2. underlying osteoporosis 3. supplementary Vitamin D in their regimen 4. advanced chronic kidney disease with estimated glomerular filtration rate (eGFR) \< 30mL/min
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients who develop hospitalized bronchiectasis exacerbation | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in St. George's Respiratory Questionnaire (SGRQ) score | From baseline to 6 and 12 months. | Scores range from 0 to 100, with higher scores indicating more limitations. |
| Change in bronchiectasis impact measure (BIM) score | From baseline to 6 and 12 months. | 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 | From baseline to 6 and 12 months. | 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). |
Countries
Hong Kong
Contacts
Primary ContactWang Chun Kwok, MBBS
Outcome results
None listed