Antioxidant Therapy to Reduce Inflammation in Sickle Cell Disease
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Anemia, Sickle Cell |
Drug: alpha-lipoic acid and acetyl-L-carnitine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Antioxidant Therapy to Reduce Inflammation in Sickle Cell Disease |
- C-Reactive Protein [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Relation between oxidative stress, inflammation and antioxidant therapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Change in inflammatory pathways in response to antioxidant therapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Change in frequency of pain episodes with antioxidant therapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Quality of life assessments on antioxidant therapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Antioxidant |
Drug: alpha-lipoic acid and acetyl-L-carnitine
Antioxidant pill or placebo will be given twice a day for 6 months.
Other Name: Juvenon
|
| Placebo Comparator: Placebo |
Drug: alpha-lipoic acid and acetyl-L-carnitine
Antioxidant pill or placebo will be given twice a day for 6 months.
Other Name: Juvenon
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 14 Years and older |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations| Contact: Olivia O Vega, CCRP | 510-428-3885 ext 4987 | ovega@mail.cho.org |
| United States, California | |
| Children's Hospital & Research Center Oakland | Recruiting |
| Oakland, California, United States, 94609 | |
| Contact: Rona Osmani 510-428-3885 ext 8227 rosmani@mail.cho.org | |
| Principal Investigator: Bruce N Ames, Ph.D. | |
| Sub-Investigator: Elliott Vichinsky, M.D. | |
| Sub-Investigator: Ashutosh Lal, M.D. | |
| Principal Investigator: | Bruce N Ames, Ph.D. | Children's Hospital & Research Center Oakland |
| Study Chair: | Elliott Vichinsky, M.D. | Children's Hospital & Research Center Oakland |
| Study Director: | Ashutosh Lal, M.D. | Children's Hospital & Research Center Oakland |
More Information
No publications provided
| Responsible Party: | Children's Hospital & Research Center Oakland |
| ClinicalTrials.gov Identifier: | NCT01054768 History of Changes |
| Other Study ID Numbers: | 2009-003, 1R21AT004493-01 |
| Study First Received: | January 20, 2010 |
| Last Updated: | August 22, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Children's Hospital & Research Center Oakland:
|
Antioxidant Inflammation Sickle Cell Disease Oxidative Stress |
Cytokines anti-inflammatory Acetylcarnitine |
Additional relevant MeSH terms:
|
Antioxidants Anemia Anemia, Sickle Cell Inflammation Hematologic Diseases Anemia, Hemolytic, Congenital Anemia, Hemolytic Hemoglobinopathies Genetic Diseases, Inborn Pathologic Processes Acetylcarnitine Carnitine |
Thioctic Acid Nootropic Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Molecular Mechanisms of Pharmacological Action Protective Agents |
ClinicalTrials.gov processed this record on May 22, 2013