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

Vitamin D Deficiency Clinical Trial

— ILD  

Official title:

Vitamin D Deficiency in Interstitial Lung Diseases

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04100226
• Other study ID #: N-140-2018
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: January 1, 2020

Study information

• Verified date: September 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 104
• Est. completion date: January 1, 2020
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Interstitial
• Vitamin D Deficiency

Intervention

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.

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (3)

Lead Sponsor	Collaborator
Cairo University	Naglaa Bakry Ahmed Elkhatib, Samah Selim Abdel Naiem Selim

Country where clinical trial is conducted

Egypt, 

Outcome

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