Clinical Trial: Antioxidant Therapy to Reduce Inflammation in Sickle Cell Disease
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Antioxidant Therapy to Reduce Inflammation in Sickle Cell Disease
Brief 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.
Detailed Summary:
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 CRP as well as other changes we 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). We want to test if inflammation in people with sickle cell disease can be reduced by the use of antioxidant compounds.
Antioxidants are nutrients (certain vitamins, minerals and enzymes) that can counteract the effects of oxidative stress arising from free radicals in our cells. The formation of free radicals is a normal cell process, but uncontrolled oxidative stress can cause problems for us. One such harmful problem is inflammation.
We know from other research studies that antioxidants help with some conditions related to inflammation. In this study the antioxidant being tested is a combination of alpha-lipoic acid and acetyl-L-carnitine, both of which are natural parts of many of the foods we eat and are needed by our cells to make energy from food.
Sponsor: Children's Hospital & Research Center Oakland
Current Primary Outcome: C-Reactive Protein [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Relation between oxidative stress, inflammation and antioxidant therapy [ Time Frame: 6 months ]
- Change in inflammatory pathways in response to antioxidant therapy [ Time Frame: 6 months ]
- Change in frequency of pain episodes with antioxidant therapy [ Time Frame: 6 months ]
- Quality of life assessments on antioxidant therapy [ Time Frame: 6 months ]
Original Secondary Outcome: Same as current
Information By: Children's Hospital & Research Center Oakland
Dates:
Date Received: January 20, 2010
Date Started: August 2009
Date Completion:
Last Updated: July 29, 2013
Last Verified: July 2013
