Severe Chronic Respiratory Failure and Citrulline

NCT03694964 | Unknown

• 1 other identifier: 38RC17.310
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Because of its very high bioavailability and its specific and direct action on protein synthesis, the investigators hypothesize that citrulline supplementation would be an innovative nutritional strategy to improve the peripheral muscle mass and strength in COPD patients with severe chronic respiratory failure. This supplementation would be more effective if the pathology is severe and the chronic systemic inflammation important. The benefits of this supplementation could help the most severe patients break out of the cycle of inactivity and thus optimize their quality of life. The main objective of this study is to evaluate the impact of 45-day nutritional supplementation with Citrulline (10 g / day) on the body composition (lean body mass) in malnourished COPD patients with severe chronic respiratory failure.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Pulmonary Disease, Chronic Obstructive; Sarcopenia; Citrulline; Body composition; Denutrition

Outcome Measures

Primary Outcomes (1)

• Impact of a 45-day nutritional supplementation with Citrulline (10 g / day) on body composition (lean body mass) of malnourished patients with COPD and severe chronic respiratory failure

  Lean mass (kg.m-2) measured by DEXA

  45 days

Secondary Outcomes (24)

• Impact of a nutritional supplementation with Citrulline on body composition

  45 days

• Impact of a nutritional supplementation with Citrulline on muscular force

  45 days

• Impact of a nutritional supplementation with Citrulline on tolerance to effort

  45 days

• Impact of a nutritional supplementation with Citrulline on BODE stage

  45 days

• Impact of a nutritional supplementation with Citrulline on inflammation and nutritional status

  45 days

Study Arms (2)

Supplementation with Citrulline

EXPERIMENTAL

Patients will receive citrulline (ProteoCIT®) 10 mg by day during 45 days

Drug: ProteoCIT®

Placebo

PLACEBO COMPARATOR

Patients will receive placebo (one tablet by day) during 45 days

Drug: Placebo Oral Tablet

Interventions

ProteoCIT® DRUG

30 patients will be randomized into the group that will receive 10 mg of citrulline and 30 patients will be randomized into the placebo group for 45 days

Supplementation with Citrulline

Placebo Oral Tablet DRUG

30 patients will be randomized into the group that will receive 10 mg of citrulline and 30 patients will be randomized into the placebo group for 45 days

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD Gold III and IV
• involuntary decrease in weight ≥ 5% in the last 6 months,
• BMI \< 25 kg.m²
• suspicion of sarcopenia marked by a score higher than 4 on the SARC-F questionnaire
• clinical stability defined by no exacerbation requiring hospitalization for at least 3 months
• long-term oxygen therapy (≥ 12h / day) and / or non-invasive ventilation for at least 6 months
• Informed consent written

You may not qualify if:

• Restrictive or mixed respiratory disease.
• Long-term systemic corticosteroids (\> 6 months per year)
• Severe and terminal renal failure (creatinine clearance \<30ml / min)
• Patients with severe hypotension, uncontrolled hypertension
• Contraindication to taking citrulline: anticoagulant and anticancer chemotherapy
• Osmotic diarrhea
• Taking food supplements whatever its form.
• Severe and / or unbalanced progressive disease that may be life-threatening in the medium term,
• Proven psychiatric pathology (schizophrenia type, dementia, bipolar / severe psychotic disorders, severe depressive syndrome),
• Cognitive or psychomotor problem that limit the realization and understanding of the different evaluations,
• Simultaneous participation in another research involving the human person
• Pregnant, parturient or breastfeeding women
• deprivation of liberty by judicial or administrative decision, protection by law, under the protection of justice, under guardianship or trusteeship,
• No affiliation to a social security scheme.

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (2)

Hôpital François Mitterrand - CHU de Dijon

Dijon, France

Location

Hôpitaux de Brabois - CHU de Nancy

Nancy, France

Location

Related Publications (3)

• Schols AM, Ferreira IM, Franssen FM, Gosker HR, Janssens W, Muscaritoli M, Pison C, Rutten-van Molken M, Slinde F, Steiner MC, Tkacova R, Singh SJ. Nutritional assessment and therapy in COPD: a European Respiratory Society statement. Eur Respir J. 2014 Dec;44(6):1504-20. doi: 10.1183/09031936.00070914. Epub 2014 Sep 18.

  PMID: 25234804 BACKGROUND

• Cano NJ, Roth H, Court-Ortune I, Cynober L, Gerard-Boncompain M, Cuvelier A, Laaban JP, Melchior JC, Pichard C, Raphael JC, Pison CM; Clinical Research Group of the Societe Francophone de Nutrition Enterale et Parenterale. Nutritional depletion in patients on long-term oxygen therapy and/or home mechanical ventilation. Eur Respir J. 2002 Jul;20(1):30-7. doi: 10.1183/09031936.02.01812001.

  PMID: 12166577 BACKGROUND

• Woo J, Leung J, Morley JE. Validating the SARC-F: a suitable community screening tool for sarcopenia? J Am Med Dir Assoc. 2014 Sep;15(9):630-4. doi: 10.1016/j.jamda.2014.04.021. Epub 2014 Jun 16.

  PMID: 24947762 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Sarcopenia

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Officials

• CHRISTOPHE PISON

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CHRISTOPHE PISON, MD PHD

CONTACT

+33(0)4 76 76 54 53; CPISON@CHU-GRENOBLE.FR

ANAIS ADOLLE

CONTACT

AADOLLE@CHU-GRENOBLE.FR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double blind study: treatment (experimental group) vs placebo (control group).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After signing the informed consent form, the patients will be randomized either in the experimental group (Citrulline (ProteiCIT®): 10 g / day) or in the control group (placebo).

Study Record Dates

• First Submitted: June 6, 2018
• First Posted: October 3, 2018
• Study Start: January 1, 2019
• Primary Completion: January 1, 2019
• Study Completion: July 1, 2021
• Last Updated: October 3, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)