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Trial record 35 of 317 for:    "Pulmonary Fibrosis, Idiopathic"

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

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.


Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nutritional Assessment in Idiopathic Pulmonary Fibrosis: a Pilot Study
Estimated Study Start Date : December 10, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 31, 2020





Primary Outcome Measures :
  1. BMI (body mass index) [ Time Frame: baseline (IPF diagnosis) ]
    kg/m2

  2. FFMI (fat free mass index) [ Time Frame: baseline (IPF diagnosis) ]
    kg/m2

  3. SMI (skeletal muscle mass index) [ Time Frame: baseline (IPF diagnosis) ]
    kg/m2

  4. BFMI (body fat mass index) [ Time Frame: baseline (IPF diagnosis) ]
    kg/m2

  5. Hand Grip [ Time Frame: baseline (IPF diagnosis) ]
    kg

  6. Abdominal circumference [ Time Frame: baseline (IPF diagnosis) ]
    cm

  7. 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

  8. 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


Secondary Outcome Measures :
  1. BMI (body mass index) [ Time Frame: 6 months after baseline ]
    kg/m2

  2. FFMI (fat free mass index) [ Time Frame: 6 months after baseline ]
    kg/m2

  3. SMI (skeletal muscle mass index) [ Time Frame: 6 months after baseline ]
    kg/m2

  4. BFMI (body fat mass index) [ Time Frame: 6 months after baseline ]
    kg/m2

  5. Hand Grip [ Time Frame: 6 months after baseline ]
    kg

  6. Abdominal circumference [ Time Frame: 6 months after baseline ]
    cm

  7. 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

  8. 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

  9. plasma calcium [ Time Frame: baseline (IPF diagnosis) and 6 months after baseline ]
    calcium level in plasma

  10. plasma vitamin D [ Time Frame: baseline (IPF diagnosis) and 6 months after baseline ]
    vitamin D level in plasma



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a diagnosis of mild to moderate Idiopathic Pulmonary Fibrosis
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03770845


Locations
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Italy
San Gerardo Hospital Recruiting
Monza, MB, Italy, 20900
Contact: Paola Faverio, MD    +39 039233 ext 9040    paola.faverio@unimib.it   
Sponsors and Collaborators
San Gerardo Hospital

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Responsible Party: Paola Faverio, Principal Investigator, San Gerardo Hospital
ClinicalTrials.gov Identifier: NCT03770845     History of Changes
Other Study ID Numbers: NUTRIPF
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Paola Faverio, San Gerardo Hospital:
nutritional status
vitamin D

Additional relevant MeSH terms:
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Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial