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

Cairo University (CU)

Status: Unknown

Conditions: Lung Diseases, Interstitial; Vitamin D Deficiency

Treatments: Dietary Supplement: Vitamin D3 (1.25 (OH)2 cholecalciferol)

Study type: Interventional

Funder types: Other

Identifiers

NCT04100226

N-140-2018

Details and patient eligibility

About

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 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.

Enrollment: 104 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

Interstitial lung patients with low vitamin D

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Vitamin D3 (1.25 (OH)2 cholecalciferol)

interstitial lung diseases patients with low vitamin D

No Intervention group

Description:

Arm 2(control group): interstitial lung diseases patients with vitamin D deficient / insufficient will receive their current treatment only without vitamin D supplementation.