Antioxidant Therapy to Reduce Inflammation in Sickle Cell Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Anemia, Sickle Cell

In brief

The purpose of this study is to determine whether alpha-lipoic acid and acetyl-L-carnitine will lower systemic inflammation in patients with Sickle Cell Disease by reducing oxidative stress, which will result in a decrease in the frequency of vaso-occlusive pain episodes and improve their quality of life.

Key facts

Study ID

NCT01054768

Run by

UCSF Benioff Children's Hospital Oakland

People needed

37

Starts

2009-08-01

Expected to finish

2013-04-01

Last updated by the study team

2021-08-03

Who can join

Age: 10 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Proven diagnosis of sickle cell disease, either homozygous sickle disease or Hb S Beta zero thalassemia genotype
• Age at entry at least 14 years. Younger children will not be included since the combination alpha-lipoic acid and acetyl-L-carnitine tablets are not available in a smaller dose at this time.

You may not qualify if…

• 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.
• Acute sickle cell disease related symptoms requiring a hospital visit in the past 4 weeks
• Women who are pregnant, attempting to get pregnant, or breast feeding
• Active participation in other investigational drug or device studies
• Participants who start hydroxyurea or regular transfusion therapy during the course of the study on the recommendation of their primary hematologist will be ineligible for further participation.

Where it is running

• Children's Hospital & Research Center Oakland — Oakland, California, United States

Full record on ClinicalTrials.gov

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