What side effects are associated with this type of intervention?

Common treatments for Sickle Cell Disease include hydroxyurea, L-glutamine, and Omega-3 fatty acids. Hydroxyurea, the first-line therapy, can cause bone marrow suppression, leading to neutropenia and thrombocytopenia, and should be avoided during pregnancy. L-glutamine, used to reduce oxidative stress, may cause mild gastrointestinal symptoms. Omega-3 fatty acids, known for their anti-inflammatory effects, are generally well-tolerated but can increase bleeding time and may interact with anticoagulant medications. These treatments aim to reduce pain and inflammation associated with SCD.

What prior FDA approvals exist?

The FDA has approved several treatments for Sickle Cell Disease that focus on reducing inflammation and pain. Hydroxyurea is one of the most established treatments, known for reducing vaso-occlusive pain episodes and other complications by increasing fetal hemoglobin levels. L-glutamine, another FDA-approved drug, helps reduce oxidative stress in red blood cells, thereby decreasing pain episodes. Omega-3 fatty acids, although not yet FDA-approved specifically for SCD, have shown promise in reducing pain and inflammation in clinical studies. These treatments aim to manage the chronic pain and inflammation associated with SCD, improving patient outcomes.

What other types of research exist?

Promising, novel alternatives to plant-based omega-3 fatty acids for SCD patients include a multi-modality approach combining a statin with suberoylanilide hydroxamic acid, and hydroxyurea, which is recommended for reducing vaso-occlusive pain and other complications. Chronic transfusions and hematopoietic cell transplantation are also potential options.

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Omega-3 Fatty Acids

Omega-3 Fatty Acids for Sickle Cell Disease

N/A

Recruiting

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a diet with plant-based omega-3 fatty acids to see if it helps children aged 5-18 with sickle cell disease by reducing their pain and inflammation.

Who is the study for?

This trial is for children and teenagers aged 5-18 with sickle cell anemia (HbSS or HbSB0 thal) who are not on chronic transfusion therapy, not taking pre/probiotic supplements, antibiotics, PPIs, and aren't pregnant or breastfeeding. They should also have no known allergy to plant-based omega-3 fatty acids.

What is being tested?

The study tests if plant-based omega-3 fatty acids can be a more acceptable treatment option for SCD patients and improve their outcomes by reducing inflammation-related pain compared to fish oil-derived omega-3s.

What are the potential side effects?

While the trial's description doesn't specify side effects of plant-based omega-3s, typical ones may include mild digestive issues or allergic reactions in those sensitive to the ingredients.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acute pain

Chronic pain

Secondary study objectives

Inflammation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Plant based omega 3 Fatty AcidExperimental Treatment1 Intervention

Participants ingest their regular diet supplemented with a plant-based omega-3-FA

Group II: Regular dietActive Control1 Intervention

Participants will continue their regular diet.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Sickle Cell Disease (SCD) include hydroxyurea, L-glutamine, and omega-3 fatty acids, each targeting different mechanisms to alleviate symptoms. Hydroxyurea increases fetal hemoglobin production, reducing the sickling of red blood cells and subsequent vaso-occlusive pain. L-glutamine decreases oxidative stress in red blood cells, which helps reduce sickling and pain episodes. Omega-3 fatty acids, known for their anti-inflammatory properties, can reduce the frequency and severity of pain crises by modulating inflammatory pathways. These treatments are crucial for SCD patients as they address the underlying pathophysiology of the disease, thereby improving quality of life and reducing complications.

Targeting novel mechanisms of pain in sickle cell disease.Plasma eicosanoid profiles determined by high-performance liquid chromatography coupled with tandem mass spectrometry in stimulated peripheral blood from healthy individuals and sickle cell anemia patients in treatment.Pilot study of omega-3 fatty acid supplements in sickle cell disease.