Vitamin D Replacement in Bronchiectasis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bronchiectasis
• Intervention / Treatment: Drug: Vitamin D3

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Wang Chun Kwok, MBBS; Phone Number: 2255 3111; Email: kwokwch@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Queen Mary Hospital
    • Contact: Wang Chun Kwok, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Vitamin D3; The non-CF bronchiectasis subjects with Vitamin D deficiency would be given 1000 IU and 2000 IU.
No Intervention: Vitamin D non-deficiency; No drug will be given to patients with Vitamin D non-deficiency.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From 1-year period before baseline to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in St. George's Respiratory Questionnaire (SGRQ) score	Scores range from 0 to 100, with higher scores indicating more limitations.	From baseline to 6 and 12 months.
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.	From baseline to 6 and 12 months.
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).	From baseline to 6 and 12 months.

Collaborators and Investigators

• Sponsor: Queen Mary Hospital, Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: August 5, 2024
• First Submitted That Met QC Criteria: August 9, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: August 9, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: UW 24-205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No