Vitamin D Replacement in Bronchiectasis

Phase 4

Recruiting

• Conditions: Bronchiectasis
• Interventions: Drug: Vitamin D3

• Registration Number: NCT06551337
• Lead Sponsor: Queen Mary Hospital, Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-17
• Status Verified: 2024-08
• Study First Submitted: 2024-08-05
• Study First Submitted QC: 2024-08-09
• Last Update Submitted: 2024-08-09
• Study First Posted: 2024-08-13
• Last Update Posted: 2024-08-13
• Primary Completion: 2026-12-31
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D replacement	Vitamin D3	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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).

Trial Locations

Locations (1)

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong