Trial | NCT02525107  Report issue

Title

Prevention of Vaso-occlusive Painful Crisis by Using Omega-3 Fatty Acid Supplements
Omega 3 Fatty Acid Therapy for Prevention of Vaso-occlusive Crisis and Manifestations in Omani Patients With Sickle Cell Disease

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    280
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].
Study Started
Sep 30
2015
Primary Completion
Jan 31
2019
Anticipated
Study Completion
Mar 31
2019
Anticipated
Last Update
Aug 17
2015
Estimate

Dietary Supplement Omega-3 capsules

SCD patients on Hydroxyurea

  • Other names: Omega-3 Fatty acid, fish oil supplement

Dietary Supplement Placebo

SCD patients on Hydroxyurea

Dietary Supplement Omega-3 capsules

SCD patients not on Hydroxyurea

  • Other names: Omega-3 Fatty acid, fish oil supplement

Dietary Supplement Placebo

SCD patients not on Hydroxyurea

SCD patients on Hydroxyurea Experimental

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]

SCD patients not on Hydroxyurea Experimental

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]

Criteria 

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.
No Results Posted