Antioxidant Therapy to Reduce Inflammation in Sickle Cell Disease

What Was Tested

This registered phase 2 trial tested L-Carnitine for anemia.

It had two arms (groups): alpha-lipoic acid and acetyl-L-carnitine (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

People with sickle cell disease have more inflammation (a response of body tissues to injury or irritation) than people without sickle cell disease.

This inflammation can be measured in the blood by checking the level of a protein called C reactive protein as well as other changes the researchers see in blood due to inflammation (such as changes in platelets and other cells).

There is even more inflammation during sickle-related complications (like pain or acute chest syndrome).

Antioxidants are nutrients (certain vitamins, minerals and enzymes) that can counteract the effects of oxidative stress arising from free radicals in their cells.

Who Took Part

The registry lists 37 actual participants took part.

It was open to people of any sex aged from 10 years with no upper age limit.

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

Examples of who could join: Proven diagnosis of sickle cell disease, either homozygous sickle disease or Hb S Beta zero thalassemia genotype.

The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: more than 3 packed red blood transfusions in the past 12 months; coexisting illness that could contribute to inflammation. these include chronic hepatitis, lupus, arthritis, inflammatory bowel disease, chronic osteomyelitis, and other similar conditions; women who are pregnant, attempting to get pregnant, or breast feeding.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The anemia participants were allocated by chance, so the L-Carnitine group and the comparison group should start out alike.

The L-Carnitine group and the comparison group ran side by side rather than switching.

As a double-blind L-Carnitine study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2009-08 with completion listed for 2013-04.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: C-Reactive Protein (time frame: 6 months).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of L-Carnitine in 37 people with anemia.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the L-Carnitine compound page, Anemia research.