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NCT Number: NCT03770845

Nutritional Assessment in Idiopathic Pulmonary Fibrosis

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

INRCA Casatenovo, Casatenovo, Lecco, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

San Gerardo Hospital

Other

Registry information

Official study title

Nutritional Assessment in Idiopathic Pulmonary Fibrosis: a Pilot Study

Acronym: NUTRIPF

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 10, 2018
Registry last updated
Sep 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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