Lung Diseases, InterstitialILDNCT04100226
Vitamin D Deficiency and Effect of Its Supplementation on Interstitial Lung Diseases(ILD).
A study testing Vitamin D3 (1.25 (OH)2 cholecalciferol) in people with Lung Diseases, Interstitial and Vitamin D Deficiency, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Diseases, Interstitial, Vitamin D Deficiency
- What is being tested?
- Vitamin D3 (1.25 (OH)2 cholecalciferol)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2019to 1 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who will be diagnosed as interstitial lung disease by multidisciplinary approach based on clinical, functional, radiological and pathological diagnosis when needed.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin D Deficiency in Interstitial Lung Diseases
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).
Read the 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.
- Conditions
- Lung Diseases, Interstitial, Vitamin D Deficiency
- Being tested
- Vitamin D3 (1.25 (OH)2 cholecalciferol)
- Keywords
- Interstitial Lung Diseases, Vitamin D Deficiency
- Medical subject headings
- Lung Diseases, Interstitial, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 (1.25 (OH)2 cholecalciferol)Dietary supplement
Also called calcium carbonate
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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} .
Measured: 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} .
Measured: 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} .
Measured: 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
Measured: baseline and 12 week (measurement at enrollment and end of study)
Secondary outcomes (1)
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).
Measured: baseline and 12 week (measurement at enrollment and end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start1 Mar 2019
- Primary completion1 Nov 2019 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Diseases, InterstitialStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Samah Selim Abdel Naiem Selim, Naglaa Bakry Ahmed Elkhatib
- Responsible party
- Principal investigator, Rania Othman Ibrahim, Cairo University
- Investigators
- Esmat Ai Ali, MD, Study chair, Professor of chest diseases,Faculty of Medicine, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100226
- Sponsor's protocol ID
- N-140-2018
- Acronym
- ILD
- Status last verified
- Sep 2019
- First submitted
- 19 Sep 2019
- Last updated
- 24 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Deficiency in Interstitial Lung Diseases
- ClinicalTrials.gov ID
- NCT04100226
- Acronym / sponsor ID
- ILD / N-140-2018
- Conditions
- Lung Diseases, Interstitial, Vitamin D Deficiency
- Keywords
- Interstitial Lung Diseases, Vitamin D Deficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Samah Selim Abdel Naiem Selim, Naglaa Bakry Ahmed Elkhatib
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 24 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Interstitial lung patients with low vitamin D | Experimental | Dietary Supplement: Vitamin D3 (1.25 (OH)2 cholecalciferol)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. |
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who will be diagnosed as interstitial lung disease by multidisciplinary approach based on clinical, functional, radiological and pathological diagnosis when needed.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3 (1.25 (OH)2 cholecalciferol)Also: calcium carbonateVitamin 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. | Dietary supplement | Interstitial lung patients with low vitamin D |
Primary outcome
change in lung functions (spirometric data) from baseline i.e change of Forced vital capacity (FVC) percent predicted values from baseline
Time frame: baseline and 12 week (measurement at enrollment and end of study)
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
Time frame: baseline and 12 week (measurement at enrollment and end of study)
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
Time frame: baseline and 12 week (measurement at enrollment and end of study)
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
Time frame: baseline and 12 week (measurement at enrollment and end of study)
change in 6-minutes walk distance walked by the patient for 6 minutes
1 secondary outcome
change in dyspnea score grading from baseline
Time frame: baseline and 12 week (measurement at enrollment and end of study)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esmat Ai Ali, MD study chair
Professor of chest diseases,Faculty of Medicine, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 (1.25 (OH)2 cholecalciferol) in people with Lung Diseases, Interstitial and Vitamin D Deficiency, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in lung functions (spirometric data) from baseline i.e change of Forced vital capacity (FVC) percent predicted values from baseline (time frame: baseline and 12 week (measurement at enrollment and end of study)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2019.