Prevention of Vaso-occlusive Painful Crisis by Using Omega-3 Fatty Acid Supplements (OM3FA)

Omega 3 Fatty Acid Therapy for Prevention of Vaso-occlusive Crisis and Manifestations in Omani Patients With Sickle Cell Disease

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 Overview

• Status: Unknown
• Conditions: Sickle Cell Disease
• Intervention / Treatment: Dietary supplement: Omega-3 capsules; Dietary supplement: Placebo; Dietary supplement: Omega-3 capsules; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 280
• Phase: Phase 3

Contacts and Locations

Study Locations

• Oman
  • Muscat, Oman, 123
    • Department of Haematology, Sultan Qaboos University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 68 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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]	Dietary supplement: Omega-3 capsules; SCD patients on Hydroxyurea; Other Names: Omega-3 Fatty acid, fish oil supplement; Dietary supplement: Placebo; SCD patients on Hydroxyurea; Dietary supplement: Omega-3 capsules; SCD patients not on Hydroxyurea; Other Names: Omega-3 Fatty acid, fish oil supplement; Dietary supplement: Placebo; SCD patients not on Hydroxyurea
Experimental: 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]	Dietary supplement: Omega-3 capsules; SCD patients on Hydroxyurea; Other Names: Omega-3 Fatty acid, fish oil supplement; Dietary supplement: Placebo; SCD patients on Hydroxyurea; Dietary supplement: Omega-3 capsules; SCD patients not on Hydroxyurea; Other Names: Omega-3 Fatty acid, fish oil supplement; Dietary supplement: Placebo; SCD patients not on Hydroxyurea

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Sultan Qaboos University
• Collaborators: Ministry of Health, Sultanate of Oman; London Metropolitian University

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: August 12, 2015
• First Submitted That Met QC Criteria: August 14, 2015
• First Posted (Estimate): August 17, 2015

Study Record Updates

• Last Update Posted (Estimate): August 17, 2015
• Last Update Submitted That Met QC Criteria: August 14, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Prevention of Vaso Occlusive Painful Crisis
• Additional Relevant MeSH Terms: Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Anemia, Sickle Cell
• Other Study ID Numbers: ORG/HSS/14/013