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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2020-01-01

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Lung Diseases, Interstitial Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Vitamin D3 (1.25 (OH)2 cholecalciferol)

Intervention Type DIETARY_SUPPLEMENT

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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calcium carbonate

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No