A Phase 2 interventional study of alpha-lipoic acid and acetyl-L-carnitine and Control in Anemia, Sickle Cell, sponsored by UCSF Benioff Children's Hospital Oakland. Completed at 1 site in United States. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2021-08-03.
Sponsored by UCSF Benioff Children's Hospital Oakland · Phase 2, Interventional, and Treatment
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 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.
1,134 studies on the registry are indexed under Anemia, Sickle Cell; 238 are open to participants now.
This study's enrollment of 37 is close to the median of 40 across 769 interventional studies indexed under Anemia, Sickle Cell.
Browse Anemia, Sickle Cell studies →UCSF Benioff Children's Hospital Oakland is the lead sponsor of 55 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
alpha-lipoic acid and acetyl-L-carnitine1400 mg tablet twice a day for 6 months.
Drug: alpha-lipoic acid and acetyl-L-carnitine
1400 mg placebo tablet twice a day for 6 months.
Drug: Control
Drug pages: Thioctic Acid · Acetylcarnitine
none to report
Also known as: Experimental
none to report
Also known as: Placebo
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.
Time frame: 6 months
First subject was enrolled 08/10/09. Length of subject involvement was 7 months. Each subject was seen once a month at Children's Hospital \& Research Center Oakland
| Milestone | Alpha-lipoic Acid and Acetyl-L-carnitine | Placebo |
|---|---|---|
| Started | 17 | 20 |
| Completed | 9 | 17 |
| Not completed | 8 | 3 |
C-Reactive Protein (CRP) was measured by a clinical laboratory. Measuring the quantity of serum CRP is helpful in recognizing inflammatory states.
| mg/l | Alpha-lipoic Acid and Acetyl-L-carnitine | Placebo |
|---|---|---|
| C-Reactive Protein | 11.4 ± 20.9 | 6.8 ± 10.3 |
Collected over 2 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Alpha-lipoic Acid and Acetyl-L-carnitine | 0/17 (0%) | 8/17 (47.1%) | 6/17 (35.3%) |
| Placebo | 0/20 (0%) | 9/20 (45%) | 12/20 (60%) |
| Event | Alpha-lipoic Acid and Acetyl-L-carnitine | Placebo |
|---|---|---|
| Vaso-occlusive painBlood and lymphatic system disorders | 6/17 | 9/20 |
| Pneumonia/Acute Chest SyndromeRespiratory, thoracic and mediastinal disorders | 2/17 | 0/20 |
| Event | Alpha-lipoic Acid and Acetyl-L-carnitine | Placebo |
|---|---|---|
| Respiratory SymptomsRespiratory, thoracic and mediastinal disorders | 3/17 | 9/20 |
| NauseaGastrointestinal disorders | 2/17 | 7/20 |
| Urinary Urgency/UTIRenal and urinary disorders | 2/17 | 5/20 |
| Age, Categorical(Participants) | Alpha-lipoic Acid and Acetyl-L-carnitine | Placebo | Total |
|---|---|---|---|
| <=18 years | 1 | 4 | 5 |
| Between 18 and 65 years | 16 | 16 | 32 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Alpha-lipoic Acid and Acetyl-L-carnitine | Placebo | Total |
|---|---|---|---|
| Female | 7 | 8 | 15 |
| Male | 10 | 12 | 22 |
Plan to share: No
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This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Thioctic Acid · Acetylcarnitine
UCSF Benioff Children's Hospital Oakland