Prevention of Vaso-occlusive Painful Crisis by Using Omega-3 Fatty Acid Supplements (OM3FA)

Sultan Qaboos University

Status and phase: Unknown; Phase 3

Conditions: Sickle Cell Disease

Treatments: Dietary Supplement: Omega-3 capsules; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02525107

ORG/HSS/14/013

Details and patient eligibility

About

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].

Enrollment: 280 estimated patients

Sex: All

Ages: 13 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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280 participants in 2 patient groups

SCD patients on Hydroxyurea

Experimental group

Description:

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\]

Treatment:

Dietary Supplement: Omega-3 capsules

Dietary Supplement: Placebo

Dietary Supplement: Placebo

Dietary Supplement: Omega-3 capsules

SCD patients not on Hydroxyurea

Experimental group

Description:

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\]

Treatment:

Dietary Supplement: Omega-3 capsules

Dietary Supplement: Placebo

Dietary Supplement: Placebo

Dietary Supplement: Omega-3 capsules