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

Sponsor:

Collaborator:

National Center for Complementary and Integrative Health (NCCIH)

Information provided by (Responsible Party):

Children's Hospital & Research Center Oakland

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Anemia, Sickle Cell	Dietary Supplement: alpha-lipoic acid and acetyl-L-carnitine Drug: Placebo	Phase 2

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.

Study Design


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

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Sickle cell disease

MedlinePlus related topics: Antioxidants

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

Genetic and Rare Diseases Information Center resources: Sickle Cell Anemia

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

C-Reactive Protein [ Time Frame: 6 months ]

Secondary Outcome Measures :

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	10 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

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

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 ( 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

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