Nutritional Assessment in Idiopathic Pulmonary Fibrosis
NUTRIPF
1 other identifier
observational
100
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2018
Typical duration for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2018
CompletedFirst Posted
Study publicly available on registry
December 10, 2018
CompletedStudy Start
First participant enrolled
December 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedSeptember 29, 2021
September 1, 2021
2.6 years
December 6, 2018
September 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
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 Outcomes (10)
BMI (body mass index)
6 months after baseline
FFMI (fat free mass index)
6 months after baseline
SMI (skeletal muscle mass index)
6 months after baseline
BFMI (body fat mass index)
6 months after baseline
Hand Grip
6 months after baseline
- +5 more secondary outcomes
Eligibility Criteria
Patients with a diagnosis of mild to moderate Idiopathic Pulmonary Fibrosis
You may qualify if:
- age greater than or equal to 18 years;
- diagnosis of IPF according to the ATS / ERS 2011 guidelines with multidisciplinary discussion
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
INRCA Casatenovo
Casatenovo, Lecco, Italy
San Gerardo Hospital
Monza, MB, 20900, Italy
G. Salvini Hospital
Garbagnate Milanese, Milano, Italy
Ospedale di Circolo
Busto Arsizio, Varese, Italy
Ospedale SS. Annunziata
Chieti, Italy
San Martino Hospital
Genova, Italy
San Giuseppe Hospital
Milan, Italy
San Paolo and San Carlo Hospital
Milan, Italy
Ospedale Maggiore Novara
Novara, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 6, 2018
First Posted
December 10, 2018
Study Start
December 10, 2018
Primary Completion
June 30, 2021
Study Completion
September 1, 2021
Last Updated
September 29, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share