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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D replacement | Active Comparator | 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. |
|
| Vitamin D non-deficiency | No Intervention | No drug will be given to patients with Vitamin D non-deficiency. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Drug | The non-CF bronchiectasis subjects with Vitamin D deficiency would be given 1000 IU and 2000 IU. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From 1-year period before baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in St. George's Respiratory Questionnaire (SGRQ) score | Scores range from 0 to 100, with higher scores indicating more limitations. | From baseline to 6 and 12 months. |
| Change in bronchiectasis impact measure (BIM) score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wang Chun Kwok, MBBS | Contact | 2255 3111 | kwokwch@hku.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary Hospital | Recruiting | Hong Kong | Hong Kong |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 6, 2024 | Aug 5, 2024 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 6, 2024 | Aug 5, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001987 | Bronchiectasis |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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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.
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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.
| From baseline to 6 and 12 months. |
| 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). | From baseline to 6 and 12 months. |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |