Antioxidant Therapy to Reduce Inflammation in Sickle Cell Disease

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital & Research Center Oakland; UCSF Benioff Children's Hospital Oakland
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)
• Treatments: Acetylcarnitine; Antioxidants; Thioctic Acid

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.