Clinical Trial: L-Citrulline in Patients With Post-Polio Syndrome
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: "Treatment With L-citrulline in Patients With Post-polio Syndrome - a Randomized Double Blind Placebo Controlled Study"
Brief Summary: The purpose of the study is to show that the intake of L-citrulline improves muscle function in patients with Post-Polio Syndrome.
Detailed Summary: This is a single center, randomized, double-blind, placebo controlled study. The study medication consists of L-citrulline, respectively placebo given orally; 5 g L-citrulline or placebo will be given three times daily. The duration of the study is 48 weeks and comprehends one screening and four study visits.
Sponsor: Dirk Fischer
Current Primary Outcome: Mean change of 6 Minute Walking Distance(6MWD) [ Time Frame: Baseline to week 48 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Mean change of MFM total score [ Time Frame: Baseline to week 48 ]
- Change of quantitative muscle MRI (IDEAL-CPMG with T₂ and lipid quantitation and dynamic 31P-MR spectroscopy) [ Time Frame: Baseline to week 48 ]
- Change of serum concentrations for markers of muscle necrosis [ Time Frame: Baseline to week 48 ]
- Change of serum concentrations for markers of oxidative stress [ Time Frame: Baseline to week 48 ]
- Change of serum concentrations for markers of nitrosative stress [ Time Frame: Baseline to week 48 ]
- Change of serum concentrations for markers of mitochondrial related genes [ Time Frame: Baseline to week 48 ]
Original Secondary Outcome: Same as current
Information By: University Hospital, Basel, Switzerland
Dates:
Date Received: June 6, 2016
Date Started: June 2016
Date Completion: December 2017
Last Updated: February 13, 2017
Last Verified: February 2017
