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Completed

NCT Number: NCT04411901

The Role of Vitamin D3 in Pediatric Bronchiectasis Severity

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

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Key information

Conditions

Cystic Fibrosis and Non CF Bronchiectasis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Children hospital

Cairo, Abbasia, 02, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Cholecalciferol (vitaminD3)

Drug

Theraputic vitamin D3 for CF and non CF bronchiectasis children

Primary outcomes

  1. reach sufficient vitamin D level

    Time frame: 6 months

    vitamin D more than 30 ng/dl

  2. decrease disease severity

    Time frame: 6 months

    decrease excerbations and increase lung function

Sponsors and collaborators

Lead sponsor

Heba Omara

Other

Registry information

Official study title

The Role of Vitamin D3 in Pediatric Bronchiectasis Severity( CF Versus Non CF Bronchioectasis)

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jun 2, 2020
Registry last updated
Jun 2, 2020

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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