Clinical trial NCT03770845: Nutritional Assessment in Idiopathic Pulmonary Fibrosis
Official title: Nutritional Assessment in Idiopathic Pulmonary Fibrosis: a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: nutritional status
vitamin D
Lead sponsor: San Gerardo Hospital
Sponsor class: OTHER
First posted: 2018-12-10
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of mild to moderate Idiopathic Pulmonary Fibrosis

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* age greater than or equal to 18 years;
* diagnosis of IPF according to the ATS / ERS 2011 guidelines with multidisciplinary discussion

Exclusion Criteria:

* 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.

Primary outcomes:
measure: BMI (body mass index)
timeFrame: baseline (IPF diagnosis)
measure: FFMI (fat free mass index)
timeFrame: baseline (IPF diagnosis)
measure: SMI (skeletal muscle mass index)
timeFrame: baseline (IPF diagnosis)
measure: BFMI (body fat mass index)
timeFrame: baseline (IPF diagnosis)
measure: Hand Grip
timeFrame: baseline (IPF diagnosis)
measure: Abdominal circumference
timeFrame: baseline (IPF diagnosis)
measure: Malnutrition Universal Screening Tool (MUST) Screening Tool (MUST)
timeFrame: baseline (IPF diagnosis)
measure: Mini Nutritional Assessment (MNA)
timeFrame: baseline (IPF diagnosis)
Secondary outcomes:
measure: BMI (body mass index)
timeFrame: 6 months after baseline
measure: FFMI (fat free mass index)
timeFrame: 6 months after baseline
measure: SMI (skeletal muscle mass index)
timeFrame: 6 months after baseline
measure: BFMI (body fat mass index)
timeFrame: 6 months after baseline
measure: Hand Grip
timeFrame: 6 months after baseline
measure: Abdominal circumference
timeFrame: 6 months after baseline
measure: Malnutrition Universal Screening Tool (MUST)
timeFrame: 6 months after baseline
measure: Mini Nutritional Assessment (MNA)
timeFrame: 6 months after baseline
measure: plasma calcium
timeFrame: baseline (IPF diagnosis) and 6 months after baseline
measure: plasma vitamin D
timeFrame: baseline (IPF diagnosis) and 6 months after baseline
Other outcomes:
Locations:
city: Casatenovo
country: Italy
facility: INRCA Casatenovo
state: Lecco
city: Monza
country: Italy
facility: San Gerardo Hospital
state: MB
city: Garbagnate Milanese
country: Italy
facility: G. Salvini Hospital
state: Milano
city: Busto Arsizio
country: Italy
facility: Ospedale di Circolo
state: Varese
city: Chieti
country: Italy
facility: Ospedale SS. Annunziata
city: Genova
country: Italy
facility: San Martino Hospital
city: Milan
country: Italy
facility: San Giuseppe Hospital
city: Milan
country: Italy
facility: San Paolo and San Carlo Hospital
city: Novara
country: Italy
facility: Ospedale Maggiore Novara
Study officials:
References: