Ubiquinol (reduced Coenzyme Q10) in patients with severe sepsis or septic shock: a randomized, double-blind, placebo-controlled, pilot trial
What this study found
Ubiquinol increased plasma CoQ10 exposure, but it did not improve vascular endothelial markers, inflammatory markers, mitochondrial injury markers, or clinical outcomes versus placebo. Compared with placebo, ubiquinol significantly increased total CoQ10 (P<0.001), CoQ10 relative to cholesterol (P<0.001), reduced CoQ10 (P=0.006), and oxidized CoQ10 (P=0.002), while the fraction of reduced CoQ10 was not significantly different (P=0.15). IL-6 levels were higher with ubiquinol at 12, 24, 48, and 72 h (P=0.02), but VEGF (P=0.41), VCAM-1 (P=0.05), TNF-α (P=0.23), IL-2 (P=0.88), IL-10 (P=0.45),…
- Study & population
- Randomized, double-blind, placebo-controlled pilot trial in adults with severe sepsis or septic shock treated at a single tertiary care hospital in Boston, Massachusetts.
- Intervention
- The active intervention was enteral ubiquinol (reduced Coenzyme Q10) at 200 mg per dose twice daily for 7 days or until hospital discharge, whichever came first.
- Key limitation
- This was a small pilot study with only 19 participants in the active arm, limiting power for clinical endpoints.
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Open PDFOriginal abstract
IntroductionWe previously found decreased levels of Coenzyme Q10 (CoQ10) in patients with septic shock. The objective of the current study was to assess whether the provision of exogenous ubiquinol (the reduced form of CoQ10) could increase plasma CoQ10 levels and improve mitochondrial function.MethodsWe performed a randomized, double-blind, pilot trial at a single, tertiary care hospital. Adults (age ≥18 years) with severe sepsis or septic shock between November 2012 and January 2014 were included. Patients received 200 mg enteral ubiquinol or placebo twice a day for up to seven days. Blood draws were obtained at baseline (0 h), 12, 24, 48, and 72 h. The primary outcome of the study was change in plasma CoQ10 parameters (total CoQ10 levels, CoQ10 levels relative to cholesterol levels, and levels of oxidized and reduced CoQ10). Secondary outcomes included assessment of: 1) vascular endothelial biomarkers, 2) inflammatory biomarkers, 3) biomarkers related to mitochondrial injury including cytochrome c levels, and 4) clinical outcomes. CoQ10 levels and biomarkers were compared between groups using repeated measures models.ResultsWe enrolled 38 patients: 19 in the CoQ10 group and 19 in the placebo group. The mean patient age was 62 ± 16 years and 47 % were female. Baseline characteristics and CoQ10 levels were similar for both groups. There was a significant increase in total CoQ10 levels, CoQ10 levels relative to cholesterol levels, and levels of oxidized and reduced CoQ10 in the ubiquinol group compared to the placebo group. We found no difference between the two groups in any of the secondary outcomes.ConclusionsIn this pilot trial we showed that plasma CoQ10 levels could be increased in patients with severe sepsis or septic shock, with the administration of oral ubiquinol. Further research is needed to address whether ubiquinol administration can result in improved clinical outcomes in this patient population.Trial registrationClinicaltrials.gov identifier NCT01948063. Registered on 18 February 2013.