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NCT Number: NCT06551337

Vitamin D Replacement in Bronchiectasis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Queen Mary Hospital

Hong Kong

Location status: Recruiting

Location contact

Wang Chun Kwok, MBBS

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Vitamin D3

Drug

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

Primary outcomes

  1. Proportion of patients who develop hospitalized bronchiectasis exacerbation

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

    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.

Secondary outcomes

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

    Time frame: From baseline to 6 and 12 months.

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

  2. Change in bronchiectasis impact measure (BIM) score

    Time frame: From baseline to 6 and 12 months.

    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.

  3. Change in Bronchiectasis Health Questionnaire (BHQ) score

    Time frame: From baseline to 6 and 12 months.

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Wang Chun Kwok, MBBS

CONTACT

[email protected]

2255 3111

Sponsors and collaborators

Lead sponsor

Queen Mary Hospital, Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 13, 2024
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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