Antioxidant Therapy to Reduce Inflammation in Sickle Cell Disease
Information source: Children's Hospital & Research Center Oakland
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anemia, Sickle Cell
Intervention: alpha-lipoic acid and acetyl-L-carnitine (Dietary Supplement); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Children's Hospital & Research Center Oakland Official(s) and/or principal investigator(s): Elliott Vichinsky, MD, Principal Investigator, Affiliation: Children's Hospital & Research Center Oakland Bruce N. Ames, PhD, Study Chair, Affiliation: Children's Hospital & Research Center Oakland Ashutosh Lal, M.D., Study Director, Affiliation: Children's Hospital & Research Center Oakland
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.
Clinical Details
Official title: Antioxidant Therapy to Reduce Inflammation in Sickle Cell Disease
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: C-Reactive Protein
Secondary outcome: Relation between oxidative stress, inflammation and antioxidant therapyChange in inflammatory pathways in response to antioxidant therapy Change in frequency of pain episodes with antioxidant therapy Quality of life assessments on antioxidant therapy
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
Minimum age: 10 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Children's Hospital & Research Center Oakland, Oakland, California 94609, United States
Additional Information
Starting date: August 2009
Last updated: July 29, 2013
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