Omega 3 Fatty Acid Therapy for Prevention of Vaso-occlusive Crisis and Manifestations in Omani Patients With Sickle Cell Disease
试验速览
- 阶段
- 3 期
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Severity of VOC
研究概览
简要总结
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].
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 13 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
SCD patients not on Hydroxyurea
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]
干预措施: Omega-3 capsules (Dietary Supplement)
SCD patients on Hydroxyurea
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]
干预措施: Placebo (Dietary Supplement)
SCD patients not on Hydroxyurea
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]
干预措施: Placebo (Dietary Supplement)
SCD patients on Hydroxyurea
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]
干预措施: Omega-3 capsules (Dietary Supplement)
结局指标
主要结局
Severity of VOC
时间窗: 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
时间窗: 52 weeks
Reduction in the number of days in hospital with VOC pain compared to the previous 52 weeks
Frequency of VOC
时间窗: 52 weeks
Reduction of the number of Emergency and Hospital visits for VOC episodes compared to the previous 52 weeks
次要结局
- Red blood cells membrane fatty acids profile(52 weeks)
研究者
Salam Alkindi
Professor & Head, Department of Haematology
Sultan Qaboos University