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Nutritional Assessment in Idiopathic Pulmonary Fibrosis (NUTRIPF)

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ClinicalTrials.gov Identifier: NCT03770845
Recruitment Status : Recruiting
First Posted : December 10, 2018
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
Paola Faverio, San Gerardo Hospital

Tracking Information
First Submitted Date December 6, 2018
First Posted Date December 10, 2018
Last Update Posted Date December 10, 2018
Estimated Study Start Date December 10, 2018
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 7, 2018)
  • BMI (body mass index) [ Time Frame: baseline (IPF diagnosis) ]
    kg/m2
  • FFMI (fat free mass index) [ Time Frame: baseline (IPF diagnosis) ]
    kg/m2
  • SMI (skeletal muscle mass index) [ Time Frame: baseline (IPF diagnosis) ]
    kg/m2
  • BFMI (body fat mass index) [ Time Frame: baseline (IPF diagnosis) ]
    kg/m2
  • Hand Grip [ Time Frame: baseline (IPF diagnosis) ]
    kg
  • Abdominal circumference [ Time Frame: baseline (IPF diagnosis) ]
    cm
  • Malnutrition Universal Screening Tool (MUST) Screening Tool (MUST) [ Time Frame: 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) [ Time Frame: baseline (IPF diagnosis) ]
    questionnaire score (maximum score 30): total score > 23.5 = normal nutritional status; total score < 23.5 = inadequate nutritional status
Original Primary Outcome Measures
 (submitted: December 7, 2018)
  • BMI (body mass index) [ Time Frame: baseline (IPF diagnosis) ]
    kg/m2
  • FFMI (fat free mass index) [ Time Frame: baseline (IPF diagnosis) ]
    kg/m2
  • SMI (skeletal muscle mass index) [ Time Frame: baseline (IPF diagnosis) ]
    kg/m2
  • BFMI (body fat mass index) [ Time Frame: baseline (IPF diagnosis) ]
    kg/m2
  • Hand Grip [ Time Frame: baseline (IPF diagnosis) ]
    kg
  • Abdominal circumference [ Time Frame: baseline (IPF diagnosis) ]
    cm
  • Malnutrition Universal Screening Tool (MUST) Screening Tool (MUST) [ Time Frame: baseline (IPF diagnosis) ]
    questionnaire score
  • Mini Nutritional Assessment (MNA) [ Time Frame: baseline (IPF diagnosis) ]
    questionnaire score
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: December 7, 2018)
  • BMI (body mass index) [ Time Frame: 6 months after baseline ]
    kg/m2
  • FFMI (fat free mass index) [ Time Frame: 6 months after baseline ]
    kg/m2
  • SMI (skeletal muscle mass index) [ Time Frame: 6 months after baseline ]
    kg/m2
  • BFMI (body fat mass index) [ Time Frame: 6 months after baseline ]
    kg/m2
  • Hand Grip [ Time Frame: 6 months after baseline ]
    kg
  • Abdominal circumference [ Time Frame: 6 months after baseline ]
    cm
  • Malnutrition Universal Screening Tool (MUST) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: baseline (IPF diagnosis) and 6 months after baseline ]
    calcium level in plasma
  • plasma vitamin D [ Time Frame: baseline (IPF diagnosis) and 6 months after baseline ]
    vitamin D level in plasma
Original Secondary Outcome Measures
 (submitted: December 7, 2018)
  • BMI (body mass index) [ Time Frame: 6 months after baseline ]
    kg/m2
  • FFMI (fat free mass index) [ Time Frame: 6 months after baseline ]
    kg/m2
  • SMI (skeletal muscle mass index) [ Time Frame: 6 months after baseline ]
    kg/m2
  • BFMI (body fat mass index) [ Time Frame: 6 months after baseline ]
    kg/m2
  • Hand Grip [ Time Frame: 6 months after baseline ]
    kg
  • Abdominal circumference [ Time Frame: 6 months after baseline ]
    cm
  • Malnutrition Universal Screening Tool (MUST) [ Time Frame: 6 months after baseline ]
    questionnaire score
  • Mini Nutritional Assessment (MNA) [ Time Frame: 6 months after baseline ]
    questionnaire score
  • plasma calcium [ Time Frame: baseline (IPF diagnosis) and 6 months after baseline ]
    calcium level in plasma
  • plasma vitamin D [ Time Frame: baseline (IPF diagnosis) and 6 months after baseline ]
    vitamin D level in plasma
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Nutritional Assessment in Idiopathic Pulmonary Fibrosis
Official Title Nutritional Assessment in Idiopathic Pulmonary Fibrosis: a Pilot Study
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with a diagnosis of mild to moderate Idiopathic Pulmonary Fibrosis
Condition Idiopathic Pulmonary Fibrosis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 7, 2018)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT03770845
Other Study ID Numbers NUTRIPF
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Paola Faverio, San Gerardo Hospital
Study Sponsor San Gerardo Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account San Gerardo Hospital
Verification Date December 2018