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| Name | Class |
|---|---|
| Ministry of Health, Sultanate of Oman | UNKNOWN |
| London Metropolitian University | UNKNOWN |
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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].
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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] |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 capsules | Dietary Supplement | SCD patients on Hydroxyurea |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Salam Alkindi, MD, FRCPI | Contact | +968-99353188 | sskindi@squ.edu.om;sskindi@yahoo.com | |
| Anil Pathare, MD,PhD | Contact | +968-99384951 | pathare@squ.edu.om;avp16@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Haematology, Sultan Qaboos University | Muscat | 123 | Oman |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| D015525 | Fatty Acids, Omega-3 |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| Placebo | Dietary Supplement | SCD patients on Hydroxyurea |
|
| Omega-3 capsules | Dietary Supplement | SCD patients not on Hydroxyurea |
|
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| Placebo | Dietary Supplement | SCD patients not on Hydroxyurea |
|
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |