Phase 2
N=37
Antioxidant Therapy to Reduce Inflammation in Sickle Cell Disease
Anemia, Sickle Cell
Bottom Line
View on ClinicalTrials.gov: NCT01054768 ↗Enrolled (actual)
37
Serious AEs
46.0%
Results posted
Aug 2021
Primary outcome: Primary: C-Reactive Protein — 11.4; 6.8 mg/l
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- alpha-lipoic acid and acetyl-L-carnitine (Drug); Control (Drug)
- Age
- Pediatric, Adult, Older Adult · 10+ yrs
- Sex
- All
- Sponsor
- UCSF Benioff Children's Hospital Oakland
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY C-Reactive Protein |
11.4; 6.8 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01054768). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.