Nutritional Assessment in Idiopathic Pulmonary Fibrosis (NUTRIPF)

Nutritional Assessment in Idiopathic Pulmonary Fibrosis: a Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Italy
  • Chieti, Italy
    • Ospedale Ss. Annunziata
  • Genova, Italy
    • San Martino Hospital
  • Milan, Italy
    • San Giuseppe Hospital
  • Milan, Italy
    • San Paolo and San Carlo Hospital
  • Novara, Italy
    • Ospedale Maggiore Novara
  • Lecco
    • Casatenovo, Lecco, Italy
      • INRCA Casatenovo
  • MB
    • Monza, MB, Italy, 20900
      • San Gerardo Hospital
  • Milano
    • Garbagnate Milanese, Milano, Italy
      • G. Salvini Hospital
  • Varese
    • Busto Arsizio, Varese, Italy
      • Ospedale di Circolo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of mild to moderate Idiopathic Pulmonary Fibrosis

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: San Gerardo Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2018
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: December 6, 2018
• First Submitted That Met QC Criteria: December 7, 2018
• First Posted (Actual): December 10, 2018

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: nutritional status; vitamin D
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: NUTRIPF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No