Antioxidant Therapy to Reduce Inflammation in Sickle Cell Disease
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ClinicalTrials.gov Identifier: NCT01054768 |
Recruitment Status
:
Completed
First Posted
: January 22, 2010
Last Update Posted
: July 31, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Anemia, Sickle Cell | Dietary Supplement: alpha-lipoic acid and acetyl-L-carnitine Drug: Placebo | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 42 participants |
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 |
Study Start Date : | August 2009 |
Actual Primary Completion Date : | April 2013 |
Actual Study Completion Date : | April 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: alpha-lipoic acid and acetyl-L-carnitine
LA and ALCAR 1400 mg tablet twice a day for 6 months.
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Dietary Supplement: alpha-lipoic acid and acetyl-L-carnitine
none to report
Other Name: Juvenon
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Placebo Comparator: Placebo
1400 mg placebo tablet twice a day for 6 months.
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Drug: Placebo
none to report
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- 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 ]

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Ages Eligible for Study: | 10 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Proven diagnosis of sickle cell disease, either Hb SS 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
Responsible Party: | Children's Hospital & Research Center Oakland |
ClinicalTrials.gov Identifier: | NCT01054768 History of Changes |
Other Study ID Numbers: |
2009-003 1R21AT004493-01 ( U.S. NIH Grant/Contract ) |
First Posted: | January 22, 2010 Key Record Dates |
Last Update Posted: | July 31, 2013 |
Last Verified: | July 2013 |
Keywords provided by Children's Hospital & Research Center Oakland:
Antioxidant Inflammation Sickle Cell Disease Oxidative Stress |
Cytokines anti-inflammatory Acetylcarnitine |
Additional relevant MeSH terms:
Inflammation Anemia, Sickle Cell Pathologic Processes Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn Antioxidants |
Thioctic Acid Acetylcarnitine Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients Growth Substances Nootropic Agents |