Vitamin D Deficiency and Effect of Its Supplementation on Interstitial Lung Diseases(ILD).

Overview

This study evaluates serum level of Vitamin D in Interstitial Lung Diseases in patients with Interstitial Lung Diseases other than connective tissue diseases associated-Interstitial Lung Diseases and effects of its supplementation. All patients will receive the standard regimen of treatment (corticosteroids and immunosuppressive drugs)and will be randomly assigned to either Group 1:who will receive Vitamin D supplementation (Interventional group)or Group 2:who will not receive Vitamin D supplementation(Control group).

Full Title of Study: “Vitamin D Deficiency in Interstitial Lung Diseases”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 1, 2019

Detailed Description

Pulmonary fibrosis was due to chronic inflammation and disordered wound healing in response to damage induced by a variety of agents such as viral infection and radiotherapy or environmental toxins.it is characterized by accumulation of myofibroblasts and excessive deposition of the extracellular matrix.Epithelial cells undergoes epithelial mesenchymal transition (EMT). Supplementation with vitamin D or its analogs suppresses lung fibrosis via triggering anti-fibrotic effect through attenuation of transforming growth factor beta (TGF-B).vitamin D can reduce TGF-B expression and attenuate TGF-B induced epithelial mesenchymal transition in lung fibroblast and epithelial cells.

Interventions

  • Dietary Supplement: Vitamin D3 (1.25 (OH)2 cholecalciferol)
    • Vitamin D 3 in a dose of 200.000 IU intramuscular injection every 2 weeks for 3 months for Vitamin D deficient interstitial lung disease patients and every month for 3 months for vitamin D insufficient interstitial lung disease patients. calcium supplementation in form of ca carbonate 600 mg oral capsule once daily for 3 months for all patients.

Arms, Groups and Cohorts

  • Experimental: Interstitial lung patients with low vitamin D
    • Arm 1:(interventional group): interstitial lung diseases patients with low vitamine D will receive Vitamin D supplementation in form of Vitamin D3 (1.25(OH)2 cholecalciferol) in dose of 200.000 IU intramuscular injection every 2 weeks for 3 months for deficient vitamin D level patients and every month for 3 months for insufficient vitamin D level patients beside ca supplementation in form ca carbonate 600 mg oral capsule once daily for 3 months for all patients in addition to current treatment.
  • No Intervention: interstitial lung diseases patients with low vitamin D
    • Arm 2(control group): interstitial lung diseases patients with vitamin D deficient / insufficient will receive their current treatment only without vitamin D supplementation.

Clinical Trial Outcome Measures

Primary Measures

  • change in lung functions (spirometric data) from baseline i.e change of Forced vital capacity (FVC) percent predicted values from baseline
    • Time Frame: baseline and 12 week (measurement at enrollment and end of study)
    • functional improvement via improvement of pulmonary function parameters as regard to volumes like {forced vital capacity(FVC) percent predicted value} .
  • change in lung functions (spirometric data) from baseline i.e change of Forced expiratory volume in 1st second (FEV1) percent predicted values from baseline
    • Time Frame: baseline and 12 week (measurement at enrollment and end of study)
    • functional improvement via improvement of pulmonary function parameters as regard to volumes like {forced expiratory volume in 1st second(FEV1) percent predicted value} .
  • change in lung functions (spirometric data) from baseline i.e change in forced expiratory flow at 25% (FEF25%) percent predicted values from baseline
    • Time Frame: baseline and 12 week (measurement at enrollment and end of study)
    • functional improvement via improvement of pulmonary function parameters as regard to velocity like {forced expiratory volume in 1st second(FEV1) percent predicted value} .
  • change in 6-minutes walk distance
    • Time Frame: baseline and 12 week (measurement at enrollment and end of study)
    • change in 6-minutes walk distance walked by the patient for 6 minutes

Secondary Measures

  • change in dyspnea score grading from baseline
    • Time Frame: baseline and 12 week (measurement at enrollment and end of study)
    • dyspnea score will be evaluated by Modified Medical Research Council(mMRC) scale which consist in 5 statements that describe almost the entire range of dyspnea from none (G 0) to almost complete in capacity ( G 4).

Participating in This Clinical Trial

Inclusion Criteria

patients who will be diagnosed as interstitial lung disease by multidisciplinary approach based on clinical, functional, radiological and pathological diagnosis when needed. Exclusion Criteria:

  • Patients who have other diseases affecting Vitamin D levels like chronic liver diseases, chronic kidney diseases and malignancy. – patients who will be unable to do pulmonary functions or 6-minutes walk test. – patients with ischemic heart diseases and congestive heart failure. – patients with connective tissue-associated interstitial lung diseases. – interstitial lung diseases exacerbation.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cairo University
  • Collaborator
    • Samah Selim Abdel Naiem Selim
  • Provider of Information About this Clinical Study
    • Principal Investigator: Rania Othman Ibrahim, Principle Investigator. – Cairo University
  • Overall Official(s)
    • Esmat Ai Ali, MD, Study Chair, Professor of chest diseases,Faculty of Medicine, Cairo University

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