Antioxidant Therapy to Reduce Inflammation in Sickle Cell Disease

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2013-04-30

Brief Summary

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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.

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Detailed Description

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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 C reactive protein 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.

Conditions

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Anemia, Sickle Cell

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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alpha-lipoic acid and acetyl-L-carnitine

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

Group Type EXPERIMENTAL

alpha-lipoic acid and acetyl-L-carnitine

Intervention Type DRUG

none to report

Placebo

1400 mg placebo tablet twice a day for 6 months.

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DRUG

none to report

Interventions

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alpha-lipoic acid and acetyl-L-carnitine

none to report

Intervention Type DRUG

Control

none to report

Intervention Type DRUG

Other Intervention Names

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Experimental Placebo

Eligibility Criteria

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Inclusion Criteria

* 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.

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.

Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No