Status:
NOT_YET_RECRUITING
Oral Citrulline Supplementation in COPD Patients With Malnutrition
Lead Sponsor:
University Hospital, Grenoble
Conditions:
Chronic Obstructive Pulmonary Disease Severe
Malnutrition
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
Chronic obstructive pulmonary disease (COPD) is complicated by malnutrition in 20-70% of cases. In COPD, low fat-free mass is associated with a higher risk of morbidity and mortality. L-citrulline is ...
Eligibility Criteria
Inclusion
- Men and women aged 50 and over
- COPD stage 3 or 4 according to GOLD criteria
- BMI \< 20 kg/m2 if \< 70 years old or \< 22 kg/m2 if ≥ 70 years old
- Suspicion of sarcopenia marked by a score of 4 or more on the SARC-F questionnaire
- Absence of severe COPD exacerbation for at least 3 months
Exclusion
- Main respiratory disease other than COPD
- Daily long-term use of systemic corticosteroids (\>6 months per year, whatever the dose)
- Severe and end-stage renal insufficiency (creatinine clearance \<30ml/min)
- Patient with severe hypotension, uncontrolled hypertension (at investigator's discretion)
- Contraindication to L-citrulline intake: VKA and/or cancer chemotherapy
- Osmotic diarrhoea
- Severe and/or uncontrolled progressive pathology likely to be life-threatening
- Psychiatric pathology (schizophrenia, dementia, severe bipolar/psychotic disorders, severe depressive syndrome)
- Pacemaker or other implanted electronic device
Key Trial Info
Start Date :
January 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 25 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06212765
Start Date
January 25 2024
End Date
September 25 2026
Last Update
January 19 2024
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