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Antioxidant Therapy to Reduce Inflammation in Sickle Cell Disease

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier:
NCT01054768
First received: January 20, 2010
Last updated: July 29, 2013
Last verified: July 2013

January 20, 2010
July 29, 2013
August 2009
April 2013   (final data collection date for primary outcome measure)
C-Reactive Protein [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01054768 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Antioxidant Therapy to Reduce Inflammation in Sickle Cell Disease
Antioxidant Therapy to Reduce Inflammation in Sickle Cell Disease

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Anemia, Sickle Cell
  • Dietary Supplement: alpha-lipoic acid and acetyl-L-carnitine
    none to report
    Other Name: Juvenon
  • Drug: Placebo
    none to report
  • Experimental: alpha-lipoic acid and acetyl-L-carnitine
    LA and ALCAR 1400 mg tablet twice a day for 6 months.
    Intervention: Dietary Supplement: alpha-lipoic acid and acetyl-L-carnitine
  • Placebo Comparator: Placebo
    1400 mg placebo tablet twice a day for 6 months.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
April 2013
April 2013   (final data collection date for primary outcome measure)

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.
Both
10 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01054768
2009-003, 1R21AT004493-01
Yes
Children's Hospital & Research Center Oakland
Children's Hospital & Research Center Oakland
National Center for Complementary and Alternative Medicine (NCCAM)
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
Children's Hospital & Research Center Oakland
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP