Idiopathic Pulmonary FibrosisNUTRIPFNCT03770845
Nutritional Assessment in Idiopathic Pulmonary Fibrosis
An observational study of Idiopathic Pulmonary Fibrosis, run by San Gerardo Hospital at 9 sites in Italy.
Trial summary
In recent years nutritional status assumed increasing importance in the evaluation of chronic respiratory diseases, considering that their clinical course is often characterized by a progressive loss of weight and reduction of muscle mass.In regards to Idiopathic Pulmonary Fibrosis (IPF), to date there are no studies… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- How many people
- 100 participants
- Where
- 9 sitesItaly
- Study dates
- 10 Dec 2018to 1 Sep 2021
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with a diagnosis of mild to moderate Idiopathic Pulmonary Fibrosis
Who may be able to join
- age greater than or equal to 18 years;
- diagnosis of IPF according to the ATS / ERS 2011 guidelines with multidisciplinary discussion
Who cannot join
- severe renal failure, defined as a GFR (glomerular filtration rate) lower than 30ml / min;
- NYHA class IV;
- severe liver failure, defined as Child-Pugh score class C;
- active solid or haematological neoplasms;
- having already received (currently or in the past) therapy with pirfenidone or nintedanib;
- inability to walk without help;
- need for oxygen therapy at rest;
- participation in other interventional experimental protocols with use of a medicinal product.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Italy9 sites
Ospedale di Circolo
Busto Arsizio, Varese
INRCA Casatenovo
Casatenovo, Lecco
Ospedale SS. Annunziata
Chieti
G. Salvini Hospital
Garbagnate Milanese, Milano
San Martino Hospital
Genova
San Giuseppe Hospital
Milan
San Paolo and San Carlo Hospital
Milan
San Gerardo Hospital
Monza, MB, 20900
Ospedale Maggiore Novara
Novara
About this study
Official title: Nutritional Assessment in Idiopathic Pulmonary Fibrosis: a Pilot Study
In recent years nutritional status assumed increasing importance in the evaluation of chronic respiratory diseases, considering that their clinical course is often characterized by a progressive loss of weight and reduction of muscle mass.In regards to Idiopathic Pulmonary Fibrosis (IPF), to date there are no studies that fully assessed the nutritional status of patients, nor the impact of the introduction of specific anti-fibrotic agents on the nutritional status of these patients.
Aim of this study is to assess the nutritional status of patients with IPF at the time of diagnosis and the impact of the introduction of specific anti-fibrotic agents, pirfenidone or nintedanib, on the nutritional status itself.
Read the detailed description
Preliminary studies on Idiopathic Pulmonary Fibrosis (IPF) seem to suggest that nutritional status has an impact on clinical outcomes, as already demonstrated in COPD. However, few data regarding this subject are available for patients with IPF.
Primary aim of this study is to assess the nutritional status of patients diagnosed with mild to moderate IPF at the time of disease diagnosis. To do so, the investigators assess the prevalence of nutritional disorders at baseline through nutritional scores evaluated with specific questionnaires and through the identification of the following metabolic phenotypes (based on those previously applied in COPD): cachexia, sarcopenia, normal nutritional status, obesity, sarcopenic obesity.
Secondary aims of this study are:
- the evaluation of the impact of the introduction of an anti-fibrotic pharmacological agent (pirfenidone or nintedanib) on the nutritional status of patients (modification of metabolic phenotypes and nutritional scores) evaluated at 6 months from the initiation of antifibrotic therapy.
- the assessment of calcium and vitamin D metabolism, by blood sampling, in patients diagnosed with mild to moderate IPF at the time of disease diagnosis and at 6 months from the initiation of antifibrotic therapy.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- nutritional status, vitamin D
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI (body mass index)
kg/m2
Measured: baseline (IPF diagnosis)
FFMI (fat free mass index)
kg/m2
Measured: baseline (IPF diagnosis)
SMI (skeletal muscle mass index)
kg/m2
Measured: baseline (IPF diagnosis)
BFMI (body fat mass index)
kg/m2
Measured: baseline (IPF diagnosis)
Hand Grip
kg
Measured: baseline (IPF diagnosis)
Abdominal circumference
cm
Measured: baseline (IPF diagnosis)
Malnutrition Universal Screening Tool (MUST) Screening Tool (MUST)
questionnaire score: score 0 = low risk of malnutrition; score 1 = medium risk of malnutrition; score equal or higher than 2 = high risk of malnutrition
Measured: baseline (IPF diagnosis)
Mini Nutritional Assessment (MNA)
questionnaire score (maximum score 30): total score > 23.5 = normal nutritional status; total score < 23.5 = inadequate nutritional status
Measured: baseline (IPF diagnosis)
Secondary outcomes (10)
BMI (body mass index)
kg/m2
Measured: 6 months after baseline
FFMI (fat free mass index)
kg/m2
Measured: 6 months after baseline
SMI (skeletal muscle mass index)
kg/m2
Measured: 6 months after baseline
BFMI (body fat mass index)
kg/m2
Measured: 6 months after baseline
Hand Grip
kg
Measured: 6 months after baseline
Abdominal circumference
cm
Measured: 6 months after baseline
Malnutrition Universal Screening Tool (MUST)
questionnaire score: score 0 = low risk of malnutrition; score 1 = medium risk of malnutrition; score equal or higher than 2 = high risk of malnutrition
Measured: 6 months after baseline
Mini Nutritional Assessment (MNA)
questionnaire score (maximum score 30): total score > 23.5 = normal nutritional status; total score < 23.5 = inadequate nutritional status
Measured: 6 months after baseline
plasma calcium
calcium level in plasma
Measured: baseline (IPF diagnosis) and 6 months after baseline
plasma vitamin D
vitamin D level in plasma
Measured: baseline (IPF diagnosis) and 6 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start10 Dec 2018
- Primary completion30 Jun 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Gerardo Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paola Faverio, San Gerardo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03770845
- Sponsor's protocol ID
- NUTRIPF
- Acronym
- NUTRIPF
- Status last verified
- Sep 2021
- First submitted
- 6 Dec 2018
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- 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 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Assessment in Idiopathic Pulmonary Fibrosis: a Pilot Study
- ClinicalTrials.gov ID
- NCT03770845
- Acronym / sponsor ID
- NUTRIPF / NUTRIPF
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- nutritional status, vitamin D
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- San Gerardo HospitalUniversity, hospital or other
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 10 Dec 2018 (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.
In recent years nutritional status assumed increasing importance in the evaluation of chronic respiratory diseases, considering that their clinical course is often characterized by a progressive loss of weight and reduction of muscle mass.In regards to Idiopathic Pulmonary Fibrosis (IPF), to date there are no studies that fully assessed the nutritional status of patients, nor the impact of the introduction of specific anti-fibrotic agents on the nutritional status of these patients.
Aim of this study is to assess the nutritional status of patients with IPF at the time of diagnosis and the impact of the introduction of specific anti-fibrotic agents, pirfenidone or nintedanib, on the nutritional status itself.
Detailed description
Preliminary studies on Idiopathic Pulmonary Fibrosis (IPF) seem to suggest that nutritional status has an impact on clinical outcomes, as already demonstrated in COPD. However, few data regarding this subject are available for patients with IPF.
Primary aim of this study is to assess the nutritional status of patients diagnosed with mild to moderate IPF at the time of disease diagnosis. To do so, the investigators assess the prevalence of nutritional disorders at baseline through nutritional scores evaluated with specific questionnaires and through the identification of the following metabolic phenotypes (based on those previously applied in COPD): cachexia, sarcopenia, normal nutritional status, obesity, sarcopenic obesity.
Secondary aims of this study are:
- the evaluation of the impact of the introduction of an anti-fibrotic pharmacological agent (pirfenidone or nintedanib) on the nutritional status of patients (modification of metabolic phenotypes and nutritional scores) evaluated at 6 months from the initiation of antifibrotic therapy.
- the assessment of calcium and vitamin D metabolism, by blood sampling, in patients diagnosed with mild to moderate IPF at the time of disease diagnosis and at 6 months from the initiation of antifibrotic therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a diagnosis of mild to moderate Idiopathic Pulmonary Fibrosis
Key inclusion criteria (2 listed)
- age greater than or equal to 18 years;
- diagnosis of IPF according to the ATS / ERS 2011 guidelines with multidisciplinary discussion
Key exclusion criteria (8 listed)
- severe renal failure, defined as a GFR (glomerular filtration rate) lower than 30ml / min;
- NYHA class IV;
- severe liver failure, defined as Child-Pugh score class C;
- active solid or haematological neoplasms;
- having already received (currently or in the past) therapy with pirfenidone or nintedanib;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
BMI (body mass index)
Time frame: baseline (IPF diagnosis)
kg/m2
FFMI (fat free mass index)
Time frame: baseline (IPF diagnosis)
kg/m2
SMI (skeletal muscle mass index)
Time frame: baseline (IPF diagnosis)
kg/m2
BFMI (body fat mass index)
Time frame: baseline (IPF diagnosis)
kg/m2
Hand Grip
Time frame: baseline (IPF diagnosis)
kg
Abdominal circumference
Time frame: baseline (IPF diagnosis)
cm
Malnutrition Universal Screening Tool (MUST) Screening Tool (MUST)
Time frame: baseline (IPF diagnosis)
questionnaire score: score 0 = low risk of malnutrition; score 1 = medium risk of malnutrition; score equal or higher than 2 = high risk of malnutrition
Mini Nutritional Assessment (MNA)
Time frame: baseline (IPF diagnosis)
questionnaire score (maximum score 30): total score > 23.5 = normal nutritional status; total score < 23.5 = inadequate nutritional status
10 secondary outcomes
BMI (body mass index)
Time frame: 6 months after baseline
FFMI (fat free mass index)
Time frame: 6 months after baseline
SMI (skeletal muscle mass index)
Time frame: 6 months after baseline
BFMI (body fat mass index)
Time frame: 6 months after baseline
Hand Grip
Time frame: 6 months after baseline
Abdominal circumference
Time frame: 6 months after baseline
Malnutrition Universal Screening Tool (MUST)
Time frame: 6 months after baseline
Mini Nutritional Assessment (MNA)
Time frame: 6 months after baseline
plasma calcium
Time frame: baseline (IPF diagnosis) and 6 months after baseline
plasma vitamin D
Time frame: baseline (IPF diagnosis) and 6 months after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Pulmonary Fibrosis, run by San Gerardo Hospital at 9 sites in Italy.
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 2 inclusion and 8 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: finished, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
BMI (body mass index) (time frame: baseline (IPF diagnosis)). The study lists 8 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 29 Sep 2021.