Vitamin D Replacement in Bronchiectasis

Queen Mary Hospital

Status and phase: Enrolling; Phase 4

Conditions: Bronchiectasis

Treatments: Drug: Vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT06551337

UW 24-205

Details and patient eligibility

About

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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

Vitamin D replacement

Active Comparator group

Description:

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.

Treatment:

Drug: Vitamin D3

Vitamin D non-deficiency

No Intervention group

Description:

No drug will be given to patients with Vitamin D non-deficiency.