Pulmonary Disease, Chronic ObstructiveNCT03694964
Severe Chronic Respiratory Failure and Citrulline
A study testing ProteoCIT® in people with Pulmonary Disease, Chronic Obstructive, run by University Hospital, Grenoble at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- ProteoCIT®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- Jan 2019to Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- At least one exacerbation requiring hospitalization in the year before inclusion.
- Informed consent written
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
ANAIS ADOLLE contact
France2 sites
Hôpital François Mitterrand - CHU de Dijon
Dijon
Hôpitaux de Brabois - CHU de Nancy
Nancy
About this study
Official title: Effects of Oral Citrulline Supplementation in Sarcopenia for Patients With Severe Chronic Respiratory Failure by COPD
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.
Read the detailed description
Denutrition in patients with COPD (Chronic Obstructive Pulmonary Disease) is characterized by muscle atrophy and loss of strength in the lower extremities. It worsens the symptomatology, exercise intolerance, impaired quality of life and prognosis of patients.
Consequence of a protein deficiency associated with systemic inflammation, denutrition is becoming increasingly important in patients with chronic respiratory failure (CRF). L-citrulline is an amino acid having a direct action on muscle protein synthesis. The citrulline supplementation is an effective treatment to fight against muscle loss in aging subjects. Its impact on the functional and nutritional status of COPD patients has not been studied.
Our main objective is to determine the impact of supplementation with Citrulline on mass and peripheral muscle strength in COPD with CRF. Our secondary objectives are to identify whether these benefits are dependent on the severity of the disease and if they are associated with increased physical activity, exercise tolerance and an improvement in symptoms and quality of life. This prospective, randomized, controlled, double-blind study will include 60 stable COPD patients (stage 3 and 4), with long-term oxygen therapy and / or non-invasive ventilation, BMI <25 kg.m2 and suspicion of sarcopenia.
For 45 days, patients will receive either citrulline (ProteoCIT®, 10mg) or placebo. The severity of COPD will be assessed by spirometry and blood gas data, the BODE index, exacerbations, comorbidities, nutritional status and systemic inflammation (CRPs, Fibrinogens). the investigators will evaluate before and after supplementation: body composition (DEXA), quadriceps strength and grip strength, walking speed, the exercise tolerance (6MWD), dyspnea (MMRC scales, BDI / TDI), quality of life (CAT and VSRQ questionnaires). Physical activity will be assessed by continuous actigraphy. This multicenter study will be conducted in 3 French hospitals: Grenoble, Nancy, Dijon.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- ProteoCIT®, Placebo Oral Tablet
- Keywords
- Pulmonary Disease, Chronic Obstructive, Sarcopenia, Citrulline, Body composition, Denutrition
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Placebo Oral TabletDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Supplementation with Citrulline | Experimental | Patients will receive citrulline (ProteoCIT®) 10 mg by day during 45 days Receives: Drug: ProteoCIT® |
| Placebo | Placebo comparator | Patients will receive placebo (one tablet by day) during 45 days Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 45 days
Secondary outcomes (24)
Impact of a nutritional supplementation with Citrulline on body composition
Regional variations of fat and bone mass measured by DEXA
Measured: 45 days
Impact of a nutritional supplementation with Citrulline on muscular force
Grip force, Maximum strength of the quadriceps
Measured: 45 days
Impact of a nutritional supplementation with Citrulline on tolerance to effort
3 min chair test
Measured: 45 days
Impact of a nutritional supplementation with Citrulline on BODE stage
BODE score - The BODE score is composed of the following parameters: the body mass index, the post-bronchodilator FEV1 expressed as a percentage of the theoretical values (airflow obstruction), the dyspnoea score measured by the modified scale of the RCM ( Dyspnea) and the distance in meters traveled during a 6-minute walk test (Exercise).Each value of each parmeter corresponds to 1 point (from 0 to 4) and we add everything. The results are: score 0 to 2: mortality 15% at 4 years; and score 7 to 10: 80% mortality at 4 years
Measured: 45 days
Impact of a nutritional supplementation with Citrulline on inflammation and nutritional status
BMI
Measured: 45 days
Impact of a nutritional supplementation with Citrulline on quality of life and dyspnea
Quality of life questionaries: COPD assessement Test (CAT): the participants answers differents questions that make it possible to measure the state of health of the patient.
Measured: 45 days
Impact of a nutritional supplementation with Citrulline on physical activity
Actigraphy
Measured: 45 days
Impact of a nutritional supplementation with Citrulline on tolerance to effort
Pulmonary function test
Measured: 45 days
Impact of a nutritional supplementation with Citrulline on tolerance to effort
Exacerbation number
Measured: 45 days
Impact of a nutritional supplementation with Citrulline on tolerance to effort
Comorbidities
Measured: 45 days
Impact of a nutritional supplementation with Citrulline on tolerance to effort
Blood gas results
Measured: 45 days
Impact of a nutritional supplementation with Citrulline on quality of life and dyspnea
Quality of life questionaries: Visual Simplified respiratory questionary (VSRQ)
Measured: 45 days
Impact of a nutritional supplementation with Citrulline on quality of life and dyspnea
Quality of life questionaries: Medical Research Council (mMRC)
Measured: 45 days
Impact of a nutritional supplementation with Citrulline on quality of life and dyspnea
Quality of life questionaries: The baseline and Transition Dyspnea Indices (TDI/BDI scale)
Measured: 45 days
Impact of a nutritional supplementation with Citrulline on quality of life and dyspnea
Quality of life questionaries: Disability Related to COPD tool (DIRECT) : a self-administered questionnaire designed to evaluate the impact of COPD on the patient's daily activities
Measured: 45 days
Impact of a nutritional supplementation with Citrulline on inflammation and nutritional status
MNA test : Mini Nutritional Assessment
Measured: 45 days
Impact of a nutritional supplementation with Citrulline on inflammation and nutritional status
a blood sample will be taken from the participants to measure the effects of citrulline on the inflammation and nutritional status of the patient. C reactive protein (CRPus), inflammation marker
Measured: 45 days
Impact of a nutritional supplementation with Citrulline on inflammation and nutritional status
Fibrinogen : inflammation marker that will be measured on a blood sample.
Measured: 45 days
Impact of a nutritional supplementation with Citrulline on inflammation and nutritional status
Transthyretinemia biological parameter that will measure the nutritional status of the patient.will be mesasured on blood sample.
Measured: 45 days
Impact of a nutritional supplementation with Citrulline on inflammation and nutritional status
Albuminemia : biological parameter that will measure the nutritional status of the patient.will be mesasured on blood sample.
Measured: 45 days
Impact of a nutritional supplementation with Citrulline on inflammation and nutritional status
glycemia biological parameter that will measure the nutritional status of the patient.will be mesasured on blood sample.
Measured: 45 days
Impact of a nutritional supplementation with Citrulline on inflammation and nutritional status
Insulinemia biological parameter that will measure the nutritional status of the patient. will be mesasured on blood sample.
Measured: 45 days
Impact of a nutritional supplementation with Citrulline on inflammation and nutritional status
Acid-aminemia biological parameter that will measure the nutritional status of the patient. will be mesasured on blood sample.
Measured: 45 days
Impact of a nutritional supplementation with Citrulline on inflammation and nutritional status
3 MethylHistine / urinary creatinine : this biological parameter will be measure on the urine: biological parameter measured on the urine. which will help to highlight the nutritional status of the patient.
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study startJan 2019 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CHRISTOPHE PISON, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03694964
- Sponsor's protocol ID
- 38RC17.310
- Status last verified
- Oct 2018
- First submitted
- 6 Jun 2018
- Last updated
- 3 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25234804Cano 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.
PubMed 12166577Woo 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.
PubMed 24947762
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Citrulline Supplementation in Sarcopenia for Patients With Severe Chronic Respiratory Failure by COPD
- ClinicalTrials.gov ID
- NCT03694964
- Acronym / sponsor ID
- 38RC17.310
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Pulmonary Disease, Chronic Obstructive, Sarcopenia, Citrulline, Body composition, Denutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Jan 2019 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 3 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Denutrition in patients with COPD (Chronic Obstructive Pulmonary Disease) is characterized by muscle atrophy and loss of strength in the lower extremities. It worsens the symptomatology, exercise intolerance, impaired quality of life and prognosis of patients.
Consequence of a protein deficiency associated with systemic inflammation, denutrition is becoming increasingly important in patients with chronic respiratory failure (CRF). L-citrulline is an amino acid having a direct action on muscle protein synthesis. The citrulline supplementation is an effective treatment to fight against muscle loss in aging subjects. Its impact on the functional and nutritional status of COPD patients has not been studied.
Our main objective is to determine the impact of supplementation with Citrulline on mass and peripheral muscle strength in COPD with CRF. Our secondary objectives are to identify whether these benefits are dependent on the severity of the disease and if they are associated with increased physical activity, exercise tolerance and an improvement in symptoms and quality of life. This prospective, randomized, controlled, double-blind study will include 60 stable COPD patients (stage 3 and 4), with long-term oxygen therapy and / or non-invasive ventilation, BMI <25 kg.m2 and suspicion of sarcopenia.
For 45 days, patients will receive either citrulline (ProteoCIT®, 10mg) or placebo. The severity of COPD will be assessed by spirometry and blood gas data, the BODE index, exacerbations, comorbidities, nutritional status and systemic inflammation (CRPs, Fibrinogens). the investigators will evaluate before and after supplementation: body composition (DEXA), quadriceps strength and grip strength, walking speed, the exercise tolerance (6MWD), dyspnea (MMRC scales, BDI / TDI), quality of life (CAT and VSRQ questionnaires). Physical activity will be assessed by continuous actigraphy. This multicenter study will be conducted in 3 French hospitals: Grenoble, Nancy, Dijon.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Supplementation with Citrulline | Experimental | Drug: ProteoCIT®Patients will receive citrulline (ProteoCIT®) 10 mg by day during 45 days |
| Placebo | Placebo comparator | Drug: Placebo Oral TabletPatients will receive placebo (one tablet by day) during 45 days |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProteoCIT®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 | Drug | Supplementation with Citrulline |
| Placebo Oral Tablet30 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 | Drug | Placebo |
Primary outcome
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
Time frame: 45 days
Lean mass (kg.m-2) measured by DEXA
24 secondary outcomes
Impact of a nutritional supplementation with Citrulline on body composition
Time frame: 45 days
Impact of a nutritional supplementation with Citrulline on muscular force
Time frame: 45 days
Impact of a nutritional supplementation with Citrulline on tolerance to effort
Time frame: 45 days
Impact of a nutritional supplementation with Citrulline on BODE stage
Time frame: 45 days
Impact of a nutritional supplementation with Citrulline on inflammation and nutritional status
Time frame: 45 days
Impact of a nutritional supplementation with Citrulline on quality of life and dyspnea
Time frame: 45 days
Impact of a nutritional supplementation with Citrulline on physical activity
Time frame: 45 days
Impact of a nutritional supplementation with Citrulline on tolerance to effort
Time frame: 45 days
Impact of a nutritional supplementation with Citrulline on tolerance to effort
Time frame: 45 days
Impact of a nutritional supplementation with Citrulline on tolerance to effort
Time frame: 45 days
Impact of a nutritional supplementation with Citrulline on tolerance to effort
Time frame: 45 days
Impact of a nutritional supplementation with Citrulline on quality of life and dyspnea
Time frame: 45 days
Impact of a nutritional supplementation with Citrulline on quality of life and dyspnea
Time frame: 45 days
Impact of a nutritional supplementation with Citrulline on quality of life and dyspnea
Time frame: 45 days
Impact of a nutritional supplementation with Citrulline on quality of life and dyspnea
Time frame: 45 days
Impact of a nutritional supplementation with Citrulline on inflammation and nutritional status
Time frame: 45 days
Impact of a nutritional supplementation with Citrulline on inflammation and nutritional status
Time frame: 45 days
Impact of a nutritional supplementation with Citrulline on inflammation and nutritional status
Time frame: 45 days
Impact of a nutritional supplementation with Citrulline on inflammation and nutritional status
Time frame: 45 days
Impact of a nutritional supplementation with Citrulline on inflammation and nutritional status
Time frame: 45 days
Impact of a nutritional supplementation with Citrulline on inflammation and nutritional status
Time frame: 45 days
Impact of a nutritional supplementation with Citrulline on inflammation and nutritional status
Time frame: 45 days
Impact of a nutritional supplementation with Citrulline on inflammation and nutritional status
Time frame: 45 days
Impact of a nutritional supplementation with Citrulline on inflammation and nutritional status
Time frame: 45 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
- Background: PubMed 25234804Schols 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.
- Background: PubMed 12166577Cano 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.
- Background: PubMed 24947762Woo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ANAIS ADOLLE contact
CHRISTOPHE PISON principal investigator
University Hospital, Grenoble
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ProteoCIT® in people with Pulmonary Disease, Chronic Obstructive, run by University Hospital, Grenoble at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact CHRISTOPHE PISON, MD PHD (+33(0)4 76 76 54 53, CPISON@CHU-GRENOBLE.FR), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03694964, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2018.