Idiopathic Pulmonary Fibrosis
Conditions
Keywords
nutritional status, vitamin D
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.
Interventions
None listed
Sponsors
San Gerardo Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| BMI (body mass index) | baseline (IPF diagnosis) | kg/m2 |
| FFMI (fat free mass index) | baseline (IPF diagnosis) | kg/m2 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Hand Grip | 6 months after baseline | kg |
| 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 |
| 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 |
| plasma calcium | baseline (IPF diagnosis) and 6 months after baseline | calcium level in plasma |
| plasma vitamin D | baseline (IPF diagnosis) and 6 months after baseline | vitamin D level in plasma |
| BMI (body mass index) | 6 months after baseline | kg/m2 |
| FFMI (fat free mass index) | 6 months after baseline | kg/m2 |
| SMI (skeletal muscle mass index) | 6 months after baseline | kg/m2 |
| BFMI (body fat mass index) | 6 months after baseline | kg/m2 |
Countries
Italy
Outcome results
None listed