Sickle Cell Disease
Conditions
Keywords
Prevention of Vaso Occlusive Painful Crisis
Brief summary
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\[SCD\].
Interventions
DIETARY_SUPPLEMENTOmega-3 capsules
SCD patients on Hydroxyurea
DIETARY_SUPPLEMENTPlacebo
SCD patients on Hydroxyurea
Sponsors
Ministry of Health, Sultanate of Oman
London Metropolitian University
Sultan Qaboos University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
13 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of VOC | 52 weeks | Reduction of the number of Emergency and Hospital visits for VOC episodes compared to the previous 52 weeks |
| Severity of VOC | 52 weeks | 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 |
| Duration of Hospitalization | 52 weeks | Reduction in the number of days in hospital with VOC pain compared to the previous 52 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Red blood cells membrane fatty acids profile | 52 weeks | Measurement of red blood cell membrane ethanolamine phosphoglyceride\[DHA, EPA, AA\] at baseline and after 52 weeks intervention period. |
Countries
Oman
Contacts
Primary ContactSalam Alkindi, MD, FRCPI
Backup ContactAnil Pathare, MD,PhD
Outcome results
None listed