The Role of Vitamin D3 in Pediatric Bronchiectasis Severity

Phase 3CompletedNCT04411901

Heba Omara40 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cystic Fibrosis and Non CF Bronchiectasis

Interventions

Cholecalciferol (vitaminD3)DRUG

Theraputic vitamin D3 for CF and non CF bronchiectasis children

Eligibility

Sex: ALLMin age: 1 YearMax age: 17 Years

Medical Language ↔ Plain English

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.

Locations (1)

Children hospital

Cairo, Abbasia, Egypt

Outcomes

Primary Outcomes

reach sufficient vitamin D level

vitamin D more than 30 ng/dl

Time frame: 6 months

decrease disease severity

decrease excerbations and increase lung function

Time frame: 6 months

Data from ClinicalTrials.gov

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