Antioxidant Therapy to Reduce Inflammation in Sickle Cell Disease - Full Text View

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	Dietary Supplement: alpha-lipoic acid and acetyl-L-carnitine Drug: Placebo	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

Resource links provided by NLM:

Genetics Home Reference related topics: sickle cell disease

MedlinePlus related topics: Antioxidants Sickle Cell Anemia

Drug Information available for: Carnitine Thioctic acid Lipoic acid Acetyl-L-carnitine

Genetic and Rare Diseases Information Center resources: Sickle Cell Anemia

U.S. FDA Resources

Further study details as provided by Children's Hospital & Research Center Oakland:

Primary Outcome Measures:

C-Reactive Protein [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]


Enrollment:	42
Study Start Date:	August 2009
Study Completion Date:	April 2013
Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Drug: Placebo none to report

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:	10 Years and older (Child, Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01054768

Locations


United States, California
Children's Hospital & Research Center Oakland
Oakland, California, United States, 94609

Sponsors and Collaborators

Children's Hospital & Research Center Oakland

National Center for Complementary and Integrative Health (NCCIH)

Investigators


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

More Information


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:	July 29, 2013
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:


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

ClinicalTrials.gov processed this record on September 28, 2016