Prevention of Vaso-occlusive Painful Crisis by Using Omega-3 Fatty Acid Supplements

Phase 3

• Conditions: Sickle Cell Disease
• Interventions: Dietary Supplement: Omega-3 capsules; Dietary Supplement: Placebo

• Registration Number: NCT02525107
• Lead Sponsor: Sultan Qaboos University

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\[SCD\].

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-08
• Study First Submitted: 2015-08-12
• Study First Submitted QC: 2015-08-14
• Last Update Submitted: 2015-08-14
• Study First Posted: 2015-08-17
• Last Update Posted: 2015-08-17
• Study Start: 2015-09
• Primary Completion: 2019-01
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 280

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SCD patients on Hydroxyurea	Omega-3 capsules	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 on Hydroxyurea	Placebo	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	Omega-3 capsules	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\]
SCD patients not on Hydroxyurea	Placebo	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\]

Primary Outcome Measures

Name	Time	Method
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
Frequency of VOC	52 weeks	Reduction of the number of Emergency and Hospital visits for VOC episodes compared to the previous 52 weeks

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Haematology, Sultan Qaboos University; 🇴🇲 Muscat, Oman