The Role of Vitamin D3 in Pediatric Bronchiectasis Severity

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

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

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis and Non CF Bronchiectasis
• Intervention / Treatment: Drug: Cholecalciferol (vitaminD3)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Abbasia
    • Cairo, Abbasia, Egypt, 02
      • Children Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: vitamin D 3; oral vitamin D3 drops and tablets	Drug: Cholecalciferol (vitaminD3); Theraputic vitamin D3 for CF and non CF bronchiectasis children

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
reach sufficient vitamin D level	vitamin D more than 30 ng/dl	6 months
decrease disease severity	decrease excerbations and increase lung function	6 months

Collaborators and Investigators

• Sponsor: Heba Omara

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2018
• Primary Completion (ACTUAL): September 6, 2018
• Study Completion (ACTUAL): March 20, 2019

Study Registration Dates

• First Submitted: May 22, 2020
• First Submitted That Met QC Criteria: May 28, 2020
• First Posted (ACTUAL): June 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 2, 2020
• Last Update Submitted That Met QC Criteria: May 28, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Bronchial Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Bronchiectasis; Cystic Fibrosis; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: Original study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No