Clinical trial NCT04100226: Vitamin D Deficiency and Effect of Its Supplementation on Interstitial Lung Diseases(ILD).
Official title: Vitamin D Deficiency in Interstitial Lung Diseases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Diseases, Interstitial
Vitamin D Deficiency
Keywords: Interstitial Lung Diseases
Vitamin D Deficiency
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Samah Selim Abdel Naiem Selim
name: Naglaa Bakry Ahmed Elkhatib
First posted: 2019-09-24
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm 1(interventional group): interstitial lung diseases patients with vitamin D deficient / insufficient will receive Vitamin D supplementation and ca in addition to current treatment.

Arm 2(control group): interstitial lung diseases patients with vitamin D deficient / insufficient will receive current treatment without vitamin D supplementation
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: change in lung functions (spirometric data) from baseline i.e change of Forced vital capacity (FVC) percent predicted values from baseline
timeFrame: baseline and 12 week (measurement at enrollment and end of study)
measure: change in lung functions (spirometric data) from baseline i.e change of Forced expiratory volume in 1st second (FEV1) percent predicted values from baseline
timeFrame: baseline and 12 week (measurement at enrollment and end of study)
measure: change in lung functions (spirometric data) from baseline i.e change in forced expiratory flow at 25% (FEF25%) percent predicted values from baseline
timeFrame: baseline and 12 week (measurement at enrollment and end of study)
measure: change in 6-minutes walk distance
timeFrame: baseline and 12 week (measurement at enrollment and end of study)
Secondary outcomes:
measure: change in dyspnea score grading from baseline
timeFrame: baseline and 12 week (measurement at enrollment and end of study)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Professor of chest diseases,Faculty of Medicine, Cairo University
name: Esmat Ai Ali, MD
role: STUDY_CHAIR
References: