Nutritional Assessment in Idiopathic Pulmonary Fibrosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Nutritional Assessment in Idiopathic Pulmonary Fibrosis: a Pilot Study

Conditions
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Idiopathic Pulmonary Fibrosis

Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI (body mass index) | kg/m2 | baseline (IPF diagnosis) | 
| FFMI (fat free mass index) | kg/m2 | baseline (IPF diagnosis) | 
| SMI (skeletal muscle mass index) | kg/m2 | baseline (IPF diagnosis) | 
| BFMI (body fat mass index) | kg/m2 | baseline (IPF diagnosis) | 
| Hand Grip | kg | baseline (IPF diagnosis) | 
| Abdominal circumference | cm | 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 | 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 | baseline (IPF diagnosis) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI (body mass index) | kg/m2 | 6 months after baseline | 
| FFMI (fat free mass index) | kg/m2 | 6 months after baseline | 
| SMI (skeletal muscle mass index) | kg/m2 | 6 months after baseline | 
| BFMI (body fat mass index) | kg/m2 | 6 months after baseline | 
| Hand Grip | kg | 6 months after baseline | 
| Abdominal circumference | cm | 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 | 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 | 6 months after baseline | 
| plasma calcium | calcium level in plasma | baseline (IPF diagnosis) and 6 months after baseline | 
| plasma vitamin D | vitamin D level in plasma | baseline (IPF diagnosis) and 6 months after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin D, nutritional status