Efficacy of Coenzyme Q10 Supplementation on Multi-Organ Dysfunction in Severely Burned Patients

NCT03968640 | Withdrawn Phase 3 FDA Drug

• 2 other identifiers: ABA-MCTG-0005W81XWH-18-2-0030
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This multi-center prospective intervention study is designed to develop coenzyme Q10 (CoQ10) supplementation as a cost-effective adjunctive therapy for burn injury. The long-term goals of this project are to establish the beneficial effects of CoQ10 on multiple organ dysfunction and on the clinical and functional outcomes of burn victims.

Conditions

Multiple Organ Failure

Keywords

MODS

Outcome Measures

Primary Outcomes (1)

• Evaluate the efficacy of reduced form CoQ10 (ubiquinol) supplementation in severely burned adult patients in the mitigation of multi-organ dysfunction (MODS)

  Evaluated by the number of the six events (i.e., renal, respiratory, cardiovascular and liver dysfunction, coagulopathy, and death

  12 weeks

Secondary Outcomes (12)

• Evaluate the effect of reduced form CoQ10 (ubiquinol) supplementation in severely burned adult patients on the following clinical outcome events and biochemical measurements in plasma and urine.

  12 weeks

• Evaluate the effect of reduced form CoQ10 (ubiquinol) supplementation in severely burned adult patients on the following clinical outcome events and biochemical measurements in plasma and urine.

  12 weeks

• Evaluate the effect of reduced form CoQ10 (ubiquinol) supplementation in severely burned adult patients on the following clinical outcome events and biochemical measurements in plasma and urine.

  12 weeks

• Evaluate the effect of reduced form CoQ10 (ubiquinol) supplementation in severely burned adult patients on the following clinical outcome events and biochemical measurements in plasma and urine.

  12 weeks

• Evaluate the effect of reduced form CoQ10 (ubiquinol) supplementation in severely burned adult patients on the following clinical outcome events and biochemical measurements in plasma and urine.

  12 weeks

Study Arms (2)

CoQ10 group

ACTIVE COMPARATOR

The patients assigned to the CoQ10 group will receive the loading dose of CoQ10 (1,800 mg/day) for 4 weeks followed by the maintenance dose of CoQ10 (600 mg/day) for 8 weeks or until hospital discharge, whichever comes first.

Dietary Supplement: CoQ10

Placebo

PLACEBO COMPARATOR

Allocation-concealed placebo will be used as an appropriate control.

Dietary Supplement: Placebo

Interventions

CoQ10 DIETARY_SUPPLEMENT

The intervention will consist of a loading dose of reduced form CoQ10 of 1,800 mg/day tid for 4 weeks to be followed by a maintenance dose of 600 mg/day once daily from weeks 5 to 12. The intervention or allocation-controlled placebo will be administered by 72 hours after injury and will continue until 12 weeks after injury or until death or discharge, whichever comes first. Oral tablets (600 mg/tablet) will be administered to CoQ10 subjects who can swallow while a liquid form (100 mg/mL) will be administered to CoQ10 subjects requiring an enteral tube for nutrition.

Also known as: Ubiquinol

CoQ10 group

Placebo DIETARY_SUPPLEMENT

The intervention will consist of a loading dose of reduced form CoQ10 of 1,800 mg/day tid for 4 weeks to be followed by a maintenance dose of 600 mg/day once daily from weeks 5 to 12. The intervention or allocation-controlled placebo will be administered by 72 hours after injury and will continue until 12 weeks after injury or until death or discharge, whichever comes first. Oral tablets (600 mg/tablet) will be administered to CoQ10 subjects who can swallow while a liquid form (100 mg/mL) will be administered to CoQ10 subjects requiring an enteral tube for nutrition.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years and older
• Burn patients with 20% or greater of total body surface area (TBSA) burn and equal to or less than 70% TBSA burn
• Capable of receiving routine oral, enteral nutrition, or a combination of routine oral and enteral nutrition
• Enrolled within 72 hours after burn injury
• Patient or legally authorized representative (LAR) who is capable of giving full informed consent
• Anticipated hospital stay: 2 weeks or more

You may not qualify if:

• Patients with liver disease (bilirubin greater than 3 or diagnosis of liver cirrhosis) at the time of admission, hyperthyroidism that currently requires treatment, diagnosis of chronic heart failure, chronic renal failure requiring hemodialysis, malignancy currently undergoing treatment, or history of cancer or hematological malignancy treatment within 5 years
• History of HIV or AIDS
• Presence of concurrent injuries apart from burn injury that may produce long-term disabilities (e.g., spinal cord injury, anoxic brain injury)
• Participation in another research study that may confound the results of this study in the opinion of the site principal investigator
• Pregnant women
• Prisoners

Sponsors & Collaborators

• American Burn Association: lead

Study Sites (1)

UTMB

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Multiple Organ Failure

Interventions

coenzyme Q10; ubiquinol

Condition Hierarchy (Ancestors)

Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Herb Phelan, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter two-arm prospective, randomized, double-blind, placebo-controlled clinical trial. 290 eligible burn patients admitted to military/civilian hospitals to be enrolled within 48 hours after severe burn injury (20%-70% TBSA burn) \& randomly assigned to either CoQ10 (n=145) or Placebo (n=145) groups. Patients in the CoQ10 group to receive loading dose of CoQ10 (1,800 mg/day) for 4 weeks and then maintenance dose of CoQ10 (600 mg/day) for 8 weeks or until hospital discharge. Allocation-concealed placebo will be used as an appropriate control.

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: May 30, 2019
• Study Start: July 1, 2018
• Primary Completion: July 17, 2020
• Study Completion: July 17, 2020
• Last Updated: July 20, 2023

Record last verified: 2023-07

Locations

US (1)