Antioxidant Therapy to Reduce Inflammation in Sickle Cell Disease
|Anemia, Sickle Cell||Dietary Supplement: alpha-lipoic acid and acetyl-L-carnitine Drug: Placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Antioxidant Therapy to Reduce Inflammation in Sickle Cell Disease|
- C-Reactive Protein [ Time Frame: 6 months ]
- 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 ]
|Study Start Date:||August 2009|
|Study Completion Date:||April 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Experimental: alpha-lipoic acid and acetyl-L-carnitine
LA and ALCAR 1400 mg tablet twice a day for 6 months.
Dietary Supplement: alpha-lipoic acid and acetyl-L-carnitine
none to report
Other Name: Juvenon
Placebo Comparator: Placebo
1400 mg placebo tablet twice a day for 6 months.
none to report
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01054768
|United States, California|
|Children's Hospital & Research Center Oakland|
|Oakland, California, United States, 94609|
|Principal Investigator:||Elliott Vichinsky, MD||Children's Hospital & Research Center Oakland|
|Study Chair:||Bruce N. Ames, PhD||Children's Hospital & Research Center Oakland|
|Study Director:||Ashutosh Lal, M.D.||Children's Hospital & Research Center Oakland|