Prospective Clinical Study on Vitamin D Replacement in Bronchiectasis - A Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Hong Kong Special Administrative Region
Queen Mary Hospital
RECRUITING
Hong Kong
Contact Information
Primary
Wang Chun Kwok, MBBS
kwokwch@hku.hk
2255 3111
Time Frame
Start Date: 2024-04-17
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 104
Treatments
Active_comparator: Vitamin D replacement
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.
No_intervention: Vitamin D non-deficiency
No drug will be given to patients with Vitamin D non-deficiency.
Related Therapeutic Areas
Sponsors
Leads: Queen Mary Hospital, Hong Kong

This content was sourced from clinicaltrials.gov