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

Not Applicable

• Conditions: Lung Diseases, Interstitial; Vitamin D Deficiency

• Registration Number: NCT04100226
• Lead Sponsor: Cairo University

Brief Summary

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).

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.

Study Timeline

• Study Start: 2019-03-01
• Status Verified: 2019-09
• Study First Submitted: 2019-09-19
• Study First Submitted QC: 2019-09-21
• Last Update Submitted: 2019-09-21
• Study First Posted: 2019-09-24
• Last Update Posted: 2019-09-24
• Primary Completion: 2019-11-01
• Study Completion: 2020-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 104

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
change in lung functions (spirometric data) from baseline i.e change of Forced vital capacity (FVC) percent predicted values from baseline	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	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	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	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 Outcome Measures

Name	Time	Method
change in dyspnea score grading from baseline	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).

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt