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Oral Citrulline Supplementation in COPD Patients With Malnutrition

Study acronym: CITRUS
StatusUnknown
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 19, 2024 (before its estimated January 25, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Oct 2023); last known: Not Yet Recruiting
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 a non-protein amino acid that has a direct effect on muscle protein synthesis. Oral supplementation with L-citrulline (10 g/day) in malnourished patients has shown to increase fat-free mass. The effects of L-citrulline supplementation in malnourished COPD patients are unknown. The main objective of this prospective, single-centre, randomised, double-blind, placebo-controlled study will be to determine the impact of 45 days of nutritional supplementation with L-citrulline (10 g/day) on lean body mass (fat-free mass index (in kg.m-2) measured by bioelectrical impedance analysis) in malnourished patients (BMI \< 20 kg/m2 if \< 70 years old or \< 22 kg/m2 if ≥ 70 years old) with COPD at stages 3-4 of the GOLD classification.
Trial Details
NCT Number NCT06212765
Lead Sponsor University Hospital, Grenoble
Conditions
(from sponsor)		 Chronic Obstructive Pulmonary Disease Severe, Malnutrition
Related terms Malnutrition, Pulmonary Disease, Chronic Obstructive
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov