Vitamin D Replacement in Bronchiectasis

NCT06551337 | Recruiting Phase 4

• 1 other identifier: UW 24-205
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiectasis

Outcome Measures

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.

  From 1-year period before baseline to 12 months

Secondary Outcomes (3)

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

  From baseline to 6 and 12 months.

• Change in bronchiectasis impact measure (BIM) score

  From baseline to 6 and 12 months.

• Change in Bronchiectasis Health Questionnaire (BHQ) score

  From baseline to 6 and 12 months.

Study Arms (2)

Vitamin D replacement

ACTIVE COMPARATOR

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

Vitamin D non-deficiency

NO INTERVENTION

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

Interventions

Vitamin D3 DRUG

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

Vitamin D replacement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Mary Hospital, Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Bronchiectasis

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Central Study Contacts

Wang Chun Kwok, MBBS

CONTACT

2255 3111; kwokwch@hku.hk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: 104 subjects will be separated into two groups according to their Baseline blood 25-hydroxyvitamin-D level: vitamin D deficient (below 50 nmol/L) and vitamin D non-deficient (at or above 50 nmol/L). There were initially 42 and 62 patients in the vitamin D deficient and vitamin D non-deficient groups respectively.

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 13, 2024
• Study Start: April 17, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)