Vitamin B-6 and Glutathione on Inflammation, Homocysteine, Oxidative Stress and Antioxidant Capacities

What Was Tested

The trial (not phased) is built around Glutathione.

It had four arms (groups): Negative control (placebo comparator), Supplement 1 (experimental), Supplement 2 (experimental) and Supplement 3 (experimental).

Dextrins.

The registry classes the interventions as dietary supplement.

More on the Plan

Vitamin B-6 and glutathione (GSH) are metabolized in liver, the role of vitamin B-6 and GSH playing in the inflammatory responses and antioxidant function would be impaired during hepatic injury.

Hematological, plasma vitamin B-6 status, GSH, inflammatory markers, homocysteine, cysteine, SAM, SAH, oxidative stress indicator, GSSG and GSH related antioxidant enzyme activities will be measured.

Who Took Part

Enrollment: 25 planned participants were the target.

It was open to people of any sex aged from 20 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age between 20 to 80 years old. Patients are diagnosed as cirrhosis or cirrhosis combined with hepatocellular carcimoma.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: patients are currently taking any nutrient supplements; patients with cardiac, renal, gastrointestinal or diabetic diseases; patients are in pregnant or lactation.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Glutathione group and the comparison group should start out alike.

The Glutathione group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Glutathione.

Those kept unaware of assignments: participant and care provider.

It started in 2014-12 with completion listed for 2016-12.

It ran at 1 site in Taiwan.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Oxidative stress marker (MDA concentation) (time frame: 3 months).

It also tracked 1 secondary outcome, for example Glutathione related enzyme activities.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Glutathione in 25 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glutathione compound page, all human trials.