Nutritional Assessment in Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis Clinical Trial

— NUTRIPF  

Official title:

Nutritional Assessment in Idiopathic Pulmonary Fibrosis: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03770845
• Other study ID #: NUTRIPF
• Status: Completed
• Start date: December 10, 2018
• Est. completion date: September 1, 2021

Study information

• Verified date: September 2021
• Source: San Gerardo Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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 information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 1, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Locations

Country	Name	City	State
Italy	Ospedale di Circolo	Busto Arsizio	Varese
Italy	INRCA Casatenovo	Casatenovo	Lecco
Italy	Ospedale SS. Annunziata	Chieti
Italy	G. Salvini Hospital	Garbagnate Milanese	Milano
Italy	San Martino Hospital	Genova
Italy	San Giuseppe Hospital	Milan
Italy	San Paolo and San Carlo Hospital	Milan
Italy	San Gerardo Hospital	Monza	MB
Italy	Ospedale Maggiore Novara	Novara

Sponsors (1)

Lead Sponsor	Collaborator
San Gerardo Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI (body mass index)	kg/m2	baseline (IPF diagnosis)
Primary	FFMI (fat free mass index)	kg/m2	baseline (IPF diagnosis)
Primary	SMI (skeletal muscle mass index)	kg/m2	baseline (IPF diagnosis)
Primary	BFMI (body fat mass index)	kg/m2	baseline (IPF diagnosis)
Primary	Hand Grip	kg	baseline (IPF diagnosis)
Primary	Abdominal circumference	cm	baseline (IPF diagnosis)
Primary	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)
Primary	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	BMI (body mass index)	kg/m2	6 months after baseline
Secondary	FFMI (fat free mass index)	kg/m2	6 months after baseline
Secondary	SMI (skeletal muscle mass index)	kg/m2	6 months after baseline
Secondary	BFMI (body fat mass index)	kg/m2	6 months after baseline
Secondary	Hand Grip	kg	6 months after baseline
Secondary	Abdominal circumference	cm	6 months after baseline
Secondary	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
Secondary	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
Secondary	plasma calcium	calcium level in plasma	baseline (IPF diagnosis) and 6 months after baseline
Secondary	plasma vitamin D	vitamin D level in plasma	baseline (IPF diagnosis) and 6 months after baseline