Table of Contents

• Trial overview
• Patient groups studied
• Trial phases and study design
• Main endpoints measured
• Key trial details
• What these trials mean for patients

Trial overview

These trials study Ascorbic Acid in different clinical settings, including severe burns, cardiac arrest shock, cardiac surgery, colorectal cancer, renal oxidative stress in type 2 diabetes, and obesity or overweight. The main goals are to see whether Ascorbic Acid is safe, whether it is tolerated, and whether it can improve important health outcomes in these groups.^{[1][2][3][4][5][6]}

The studies are not all the same. Some test Ascorbic Acid alone, while others study it together with other treatments or standard care.^[1][4][5]

Patient groups studied

The trials include several different patient groups. One study is in severely burned patients, another in patients with post-cardiac arrest shock, and another in cardiac surgery patients in intensive care.^[4][5][1]

Other studies include people with pMMR/MSS colon cancer, which means a type of colorectal cancer defined by tumor testing, people with type 2 diabetes, and people living with overweight or obesity.^[3][6][2]

Trial phases and study design

Most of the Ascorbic Acid studies in the source data are Phase 2 trials, which usually look for early signs of benefit and continue safety testing in a smaller group of patients.^{[1][3][4][5][6]}

One study is a Phase 3 trial in type 2 diabetes, which is a larger study designed to compare outcomes more formally. The obesity study is a randomized, single-blind, placebo-controlled, multiple-ascending-dose study, which means patients are assigned to treatment groups by chance, one side does not know all group assignments, and the dose is increased step by step across groups.^[2][6]

Main endpoints measured

The main results vary by trial, but many focus on safety and tolerability. These include adverse events, serious adverse events, vital signs, electrocardiogram results, and clinical laboratory tests.^[6][1]

Some studies measure disease-specific outcomes. For example, the burn study looks at persistent organ dysfunction and death at 28 days, the cardiac arrest study looks at weaning from vasopressors by day 3, the cardiac surgery study looks at the area under the curve of IL-6, and the colorectal cancer study looks at pathological response rate.^[4][5][1][3]

Other studies measure body weight change, weight loss of at least 5%, renal perfusion after vitamin C infusion, and how the body handles the study treatment over time through pharmacokinetic measures such as AUC, Cmax, and half-life.^[6][2][1]

Key trial details

• Cardiac surgery study: This Phase 2 trial in 60 patients tests Ascorbic Acid in people having open-heart surgery or treated in intensive care. The main endpoint is the area under the curve of serum IL-6 from baseline to 72 hours after surgery, which measures the level of inflammation over time.^[1]

• Cardiac arrest shock study: This Phase 2 study includes 234 patients and looks at early intravenous high-dose Ascorbic Acid after out-of-hospital cardiac arrest with shock. The main endpoint is the cumulative incidence of weaning from vasopressors at day 3, meaning how many patients no longer need medicines that support blood pressure.^[5]

• Colorectal cancer pilot study: This Phase 2 trial includes 24 patients with pMMR/MSS colon cancer. It studies Ascorbic Acid together with Ipilimumab and Nivolumab before surgery, and the main endpoint is pathological response rate, which checks how the tumor tissue responds after treatment.^[3]

• Burn injury study: This Phase 2 multicenter randomized trial includes 373 severely burned patients. It studies intravenous Ascorbic Acid added to standard care, and the main endpoint is persistent organ dysfunction and death at 28 days, a combined measure of survival and organ support needs.^[4]

• Renal oxidative stress study: This Phase 3 trial in 75 people with type 2 diabetes looks at renal vascular oxidative stress, using vitamin C infusion as part of the assessment. The primary endpoint is the impact of finerenone on renal perfusion after vitamin C infusion compared with placebo.^[2]

• Obesity and overweight study: This Phase 2 trial includes 360 participants with obesity or overweight and studies subcutaneous AZD9550 and AZD6234, with Ascorbic Acid not listed as the study drug in the source data. It is included here only because the user source set contains mixed trial records, but it is not an Ascorbic Acid trial and should not be counted as one.^[6]

What these trials mean for patients

For patients, these studies show that Ascorbic Acid is being tested in serious hospital conditions and in cancer and metabolic disease settings. The trials are trying to find out if Ascorbic Acid can improve recovery, reduce inflammation, help with organ support, or improve treatment response, while also checking safety carefully.^{[1][3][4][5][2]}

Because the studies are different in purpose and design, participation depends on the condition being studied and the trial rules for that specific study. The source data show that some trials are completed and others are still authorised.^{[1][2][3][4][5]}