Back to results

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

Primary Purpose

Lung Diseases, Interstitial, Vitamin D Deficiency

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Vitamin D3 (1.25 (OH)2 cholecalciferol)

About this trial

This is an interventional other trial for Lung Diseases, Interstitial focused on measuring Interstitial Lung Diseases, Vitamin D Deficiency

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Interstitial lung patients with low vitamin D

interstitial lung diseases patients with low vitamin D

Arm 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.

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

Outcomes

Primary Outcome Measures

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} .

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} .

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} .

change in 6-minutes walk distance

change in 6-minutes walk distance walked by the patient for 6 minutes

Secondary Outcome Measures

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).

Full Information

NCT ID

NCT04100226

First Posted

September 19, 2019

Last Updated

September 21, 2019

Sponsor

Cairo University

Collaborators

Samah Selim Abdel Naiem Selim, Naglaa Bakry Ahmed Elkhatib

1. Study Identification

Unique Protocol Identification Number

NCT04100226

Brief Title

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

Acronym

ILD

Official Title

Vitamin D Deficiency in Interstitial Lung Diseases

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Unknown status

Study Start Date

March 1, 2019 (Actual)

Primary Completion Date

November 1, 2019 (Anticipated)

Study Completion Date

January 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

Collaborators

Samah Selim Abdel Naiem Selim, Naglaa Bakry Ahmed Elkhatib

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Diseases, Interstitial, Vitamin D Deficiency

Keywords

Interstitial Lung Diseases, Vitamin D Deficiency

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

Masking

None (Open Label)

Allocation

Randomized

Enrollment

104 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Interstitial lung patients with low vitamin D

Arm Type

Experimental

Arm Description

Arm Title

interstitial lung diseases patients with low vitamin D

Arm Type

No Intervention

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D3 (1.25 (OH)2 cholecalciferol)

Other Intervention Name(s)

calcium carbonate

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

functional improvement via improvement of pulmonary function parameters as regard to volumes like {forced vital capacity(FVC) percent predicted value} .

Time Frame