The Role of Vitamin D3 in Pediatric Bronchiectasis Severity

H

Heba Omara

Status and phase

Completed
Phase 3
Phase 2

Conditions

Cystic Fibrosis and Non CF Bronchiectasis

Treatments

Drug: Cholecalciferol (vitaminD3)

Study type

Interventional

Funder types

Other

Identifiers

NCT04411901
Original study

Details and patient eligibility

About

Vitamin D3 therapy was effective in decreasing the frequency of pulmonary exacerbations and preserving lung functions , thereby improving the disease severity even more in non CF than CF bronchiectasis patients

Full description

Objectives: To compare the effect of vitamin D3 on modifying the disease severity in CF and non CF bronchiectasis pediatric patients. Patients and Methods: This was a randomized clinical trial evaluating the role of oral vitamin D3 supplementation for 6 months in forty patients with CF and non CF bronchiectasis under the age of 18 years with vitamin D deficiency or insufficiency . The primary outcome was to reach the sufficient Vitamin D level. The secondary outcome was to follow up the frequency of pulmonary exacerbations and lung function after vitamin D3 supplementation.

Enrollment

40 patients

Sex

All

Ages

1 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • ages less than 18 years .
  • Patients with documented diagnosis of CF (by the presence of a twice positive sweat chloride test and or paired CFTR DNA genetic mutations).
  • Patients with non CF bronchiectasis diagnosed clinically and radiologically ( sweat chloride test negative) with a high resolution CT-confirmed diagnosis and clinical history consistent with bronchiectasis .
  • Vitamin D deficient or insufficient CF and non CF bronchiectasis patients

Exclusion Criteria: if they had

  • sufficient Vitamin D level .
  • chronic lung diseases other than CF and non CF bronchiectasis , liver or renal diseases.
  • reported taking vitamin-D supplements or steroid therapy in the last 6 weeks.

Trial design

40 participants in 1 patient group

vitamin D 3
Experimental group
Description:
oral vitamin D3 drops and tablets
Treatment:
Drug: Cholecalciferol (vitaminD3)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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