Human Biomarkers for Assessing Copper Deficiency

What Was Tested

In this phase 1 trial, researchers set out to test Copper (Supplement).

Copper is an essential nutrient for humans and is cofactor in enzymes that participate in critical body functions.

Insufficient copper can lead to hematological and neurological abnormalities that may be irreversible if left untreated.

Copper deficiency is believed to be rare in the U.S. population because typical dietary intake is usually sufficient to meet requirements.

It had three arms (groups): Aim 1; Biomarkers (no intervention), Copper supplement Arm (experimental) and Normal Controls (no intervention).

Blood concentrations of copper coenzymes will be monitored for 1 year.

Normal subjects will be used to generate reference measures.

The registry classes the interventions as dietary supplement.

Who Took Part

70 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

How the Study Was Run

It was run as a randomized, single-group and double-blind study.

The participants were allocated by chance, so the Copper (Supplement) group and the comparison group should start out alike.

As a double-blind Copper (Supplement) study, the assignments were hidden from both participants and investigators until the end.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

Those kept unaware of assignments: participant and investigator.

It started in 2010-11 with completion listed for 2018-12.

It ran at 1 site in United States.

Its stated primary purpose is diagnostic.

What Was Measured

Primary outcome: copper co-enzymes (time frame: 1 year).

It also tracked 1 secondary outcome, for example blood copper concentrations.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Copper (Supplement) in 70 people.

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

More context: the Copper (Supplement) compound page, all human trials.