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

NCT04100226 | Unknown

• 1 other identifier: N-140-2018
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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).

Conditions

Lung Diseases, Interstitial; Vitamin D Deficiency

Keywords

Interstitial Lung Diseases; Vitamin D Deficiency

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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 Outcomes (1)

• change in dyspnea score grading from baseline

  baseline and 12 week (measurement at enrollment and end of study)

Study Arms (2)

Interstitial lung patients with low vitamin D

EXPERIMENTAL

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.

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

interstitial lung diseases patients with low vitamin D

NO INTERVENTION

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

Interventions

Vitamin D3 (1.25 (OH)2 cholecalciferol) 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.

Also known as: calcium carbonate

Interstitial lung patients with low vitamin D

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who will be diagnosed as interstitial lung disease by multidisciplinary approach based on clinical, functional, radiological and pathological diagnosis when needed.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead
• Samah Selim Abdel Naiem Selim: collaborator
• Naglaa Bakry Ahmed Elkhatib: collaborator

Study Sites (1)

Cairo University

Cairo, 12613, Egypt

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial; Vitamin D Deficiency

Interventions

Cholecalciferol; Calcium Carbonate

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

Study Officials

• Esmat Ai Ali, MD

  Professor of chest diseases,Faculty of Medicine, Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator.

Model Details: 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

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 24, 2019
• Study Start: March 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: January 1, 2020
• Last Updated: September 24, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)