Prevention of Vaso-occlusive Painful Crisis by Using Omega-3 Fatty Acid Supplements

Study Overview
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Brief Summary
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140 SCD patients [70 on Hydroxyurea] will receive Omega-3 capsules whereas another 140 SCD patients [70 on Hydroxyurea] will receive placebo and will be recruited from the Sultan Qaboos University Hospital [SQUH] haematology specialty clinics. Patients will be randomized in a 1:1 ratio to receive placebo or Omega-3 for 52 weeks. The aim is to investigate the therapeutic potential of omega-3 fatty acids in the prevention of vaso-occlusive crisis in Omani patients with sickle cell disease[SCD].

Official Title
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Omega 3 Fatty Acid Therapy for Prevention of Vaso-occlusive Crisis and Manifestations in Omani Patients With Sickle Cell Disease

Conditions
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Sickle Cell Disease

Intervention / Treatment
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* Dietary Supplement: Omega-3 capsules
* Dietary Supplement: Placebo
* Dietary Supplement: Omega-3 capsules
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate to severe Sickle cell disease patients. Patients already receiving Hydroxyurea[HU] are eligible for the study. Patients able and willing to comply with the procedures in the study protocol. Exclusion Criteria: Acute episodes (infection, vaso-occlusive crises (VOC), acute chest syndrome (ACS), stroke, priapism, splenic sequestration) in the past one month before enrolment. Previous stroke, and other co-morbid diseases like Essential Hypertension, Cardiomyopathy and Heart failure, Diabetes, Chronic Renal Failure. Patients with a history of adverse reaction to omega-3 fatty acid supplementation. Blood transfusion in the previous 3 months.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCD patients on Hydroxyurea<br>Omega-3 capsules [750 mg], 4 capsules a day for 52 weeks. [Each capsule will contain 417.9mg Docosahexaenoic acid [DHA], 50.8 mg Eicosapentaenoic acid [EPA] and 11.9mg Arachidonic acid [AA] and 1000 IU Vitamin E] | Dietary Supplement: Omega-3 capsules<br>* SCD patients on Hydroxyurea<br>* Other names: Omega-3 Fatty acid, fish oil supplement;Dietary Supplement: Placebo<br>* SCD patients on Hydroxyurea<br>|
| Experimental: SCD patients not on Hydroxyurea<br>Dietary Supplement: Placebo [730 mg], 4 capsules a day for 52 weeks.[Each capsule will contain 538.2mg Oleic Acid [OA] and 1000 IU Vitamin E] | Dietary Supplement: Omega-3 capsules<br>* SCD patients not on Hydroxyurea<br>* Other names: Omega-3 Fatty acid, fish oil supplement;Dietary Supplement: Placebo<br>* SCD patients not on Hydroxyurea<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of VOC | Reduction of the number of Emergency and Hospital visits for VOC episodes compared to the previous 52 weeks | 52 weeks | 
| Severity of VOC | Reduction in the average visual analog score for pain with scores ranging from 0[no pain] to 10[worst possible pain] recorded during VOC episodes compared to the previous 52 weeks | 52 weeks | 
| Duration of Hospitalization | Reduction in the number of days in hospital with VOC pain compared to the previous 52 weeks | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Red blood cells membrane fatty acids profile | Measurement of red blood cell membrane ethanolamine phosphoglyceride[DHA, EPA, AA] at baseline and after 52 weeks intervention period. | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention of Vaso Occlusive Painful Crisis