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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 therapy

Change 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

Page last updated: August 23, 2015

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