NCT06551337 Vitamin D Replacement in Bronchiectasis
| NCT ID | NCT06551337 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Queen Mary Hospital, Hong Kong |
| Condition | Bronchiectasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 104 participants |
| Start Date | 2024-04-17 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 104 participants in total. It began in 2024-04-17 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06551337 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bronchiectasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06551337 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06551337 currently recruiting?
Yes, NCT06551337 is actively recruiting participants. Contact the research team at kwokwch@hku.hk for enrollment information.
Where is the NCT06551337 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT06551337 clinical trial?
NCT06551337 is sponsored by Queen Mary Hospital, Hong Kong. The trial plans to enroll 104 participants.