Vitamin D Replacement in Bronchiectasis

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorQueen Mary Hospital, Hong Kong

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

underlying asthma, COPD and other co-existing respiratory diseases

underlying osteoporosis

supplementary Vitamin D in their regimen

advanced chronic kidney disease with estimated glomerular filtration rate (eGFR) < 30mL/min

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vitamin D3

    Drug

    The non-CF bronchiectasis subjects with Vitamin D deficiency would be given 1000 IU and 2000 IU.

Treatment groups

104 Participants
are divided into 2 treatment groups
Group A: Vitamin D replacementActive comparator 1 intervention
Group B: Vitamin D non-deficiencyNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
From 1-year period before baseline to 12 months

Secondary outcomes

1

Change in St. George's Respiratory Questionnaire (SGRQ) score

Scores range from 0 to 100, with higher scores indicating more limitations.

Time frame
From baseline to 6 and 12 months.
2

Change in bronchiectasis impact measure (BIM) score

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.

Time frame
From baseline to 6 and 12 months.
3

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).

Time frame
From baseline to 6 and 12 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Queen Mary Hospital, Hong Kong

Lead sponsor

The University of Hong Kong

Sponsor institution