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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
280
SCD patients on Hydroxyurea
SCD patients on Hydroxyurea
SCD patients not on Hydroxyurea
Department of Haematology, Sultan Qaboos University
Muscat, Oman
Frequency of VOC
Reduction of the number of Emergency and Hospital visits for VOC episodes compared to the previous 52 weeks
Time frame: 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
Time frame: 52 weeks
Duration of Hospitalization
Reduction in the number of days in hospital with VOC pain compared to the previous 52 weeks
Time frame: 52 weeks
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.
Time frame: 52 weeks
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SCD patients not on Hydroxyurea