Nutritional Assessment in Idiopathic Pulmonary Fibrosis
- Conditions
- Idiopathic Pulmonary Fibrosis
- Registration Number
- NCT03770845
- Lead Sponsor
- San Gerardo Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- age greater than or equal to 18 years;
- diagnosis of IPF according to the ATS / ERS 2011 guidelines with multidisciplinary discussion
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method BMI (body mass index) baseline (IPF diagnosis) kg/m2
FFMI (fat free mass index) baseline (IPF diagnosis) kg/m2
SMI (skeletal muscle mass index) baseline (IPF diagnosis) kg/m2
BFMI (body fat mass index) baseline (IPF diagnosis) kg/m2
Hand Grip baseline (IPF diagnosis) kg
Abdominal circumference baseline (IPF diagnosis) cm
Malnutrition Universal Screening Tool (MUST) Screening Tool (MUST) 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) baseline (IPF diagnosis) questionnaire score (maximum score 30): total score \> 23.5 = normal nutritional status; total score \< 23.5 = inadequate nutritional status
- Secondary Outcome Measures
Name Time Method Abdominal circumference 6 months after baseline cm
Malnutrition Universal Screening Tool (MUST) 6 months after baseline questionnaire score: score 0 = low risk of malnutrition; score 1 = medium risk of malnutrition; score equal or higher than 2 = high risk of malnutrition
BMI (body mass index) 6 months after baseline kg/m2
SMI (skeletal muscle mass index) 6 months after baseline kg/m2
Hand Grip 6 months after baseline kg
plasma calcium baseline (IPF diagnosis) and 6 months after baseline calcium level in plasma
FFMI (fat free mass index) 6 months after baseline kg/m2
plasma vitamin D baseline (IPF diagnosis) and 6 months after baseline vitamin D level in plasma
BFMI (body fat mass index) 6 months after baseline kg/m2
Mini Nutritional Assessment (MNA) 6 months after baseline questionnaire score (maximum score 30): total score \> 23.5 = normal nutritional status; total score \< 23.5 = inadequate nutritional status
Trial Locations
- Locations (9)
INRCA Casatenovo
๐ฎ๐นCasatenovo, Lecco, Italy
San Gerardo Hospital
๐ฎ๐นMonza, MB, Italy
Ospedale SS. Annunziata
๐ฎ๐นChieti, Italy
San Martino Hospital
๐ฎ๐นGenova, Italy
San Giuseppe Hospital
๐ฎ๐นMilan, Italy
San Paolo and San Carlo Hospital
๐ฎ๐นMilan, Italy
Ospedale Maggiore Novara
๐ฎ๐นNovara, Italy
Ospedale di Circolo
๐ฎ๐นBusto Arsizio, Varese, Italy
G. Salvini Hospital
๐ฎ๐นGarbagnate Milanese, Milano, Italy