Antioxidant Therapy to Reduce Inflammation in Sickle Cell Disease

NCT01054768 | Completed Phase 2 Results DMC

• 2 other identifiers: 2009-0031R21AT004493-01
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia, Sickle Cell

Keywords

Antioxidant; Inflammation; Sickle Cell Disease; Oxidative Stress; Cytokines; anti-inflammatory; Acetylcarnitine

Outcome Measures

Primary Outcomes (1)

• C-Reactive Protein

  C-Reactive Protein (CRP) was measured by a clinical laboratory. Measuring the quantity of serum CRP is helpful in recognizing inflammatory states.

  6 months

Study Arms (2)

alpha-lipoic acid and acetyl-L-carnitine

EXPERIMENTAL

alpha-lipoic acid and acetyl-L-carnitine1400 mg tablet twice a day for 6 months.

Drug: alpha-lipoic acid and acetyl-L-carnitine

Placebo

PLACEBO COMPARATOR

1400 mg placebo tablet twice a day for 6 months.

Drug: Control

Interventions

alpha-lipoic acid and acetyl-L-carnitine DRUG

none to report

Also known as: Experimental

alpha-lipoic acid and acetyl-L-carnitine

Control DRUG

none to report

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Proven diagnosis of sickle cell disease, either homozygous sickle disease 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UCSF Benioff Children's Hospital Oakland: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Children's Hospital & Research Center Oakland

Oakland, California, 94609, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Inflammation

Interventions

Thioctic Acid; Acetylcarnitine

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids; Carnitine; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines

Results Point of Contact

• Title: Ashutosh Lal, MD
• Organization: Children's Hospital & Research Center at Oakland

ashutosh.lal@ucsf.edu

5104283172

Study Officials

• Elliott Vichinsky, M.D.

  UCSF Benioff Children's Hospital Oakland

  PRINCIPAL INVESTIGATOR

• Bruce N. Ames, Ph.D.

  UCSF Benioff Children's Hospital Oakland

  STUDY CHAIR

• Ashutosh Lal, M.D.

  UCSF Benioff Children's Hospital Oakland

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2010
• First Posted: January 22, 2010
• Study Start: August 1, 2009
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: August 3, 2021
• Results First Posted: August 3, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)