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

• Register: ClinicalTrials.gov
• Last refreshed on: 24 August 2015
• Main ID: NCT02525107
• Date of registration: 12/08/2015
• Prospective Registration: Yes
• Primary sponsor: Sultan Qaboos University
• Public title: Prevention of Vaso-occlusive Painful Crisis by Using Omega-3 Fatty Acid Supplements OM3FA
• Scientific title: Omega 3 Fatty Acid Therapy for Prevention of Vaso-occlusive Crisis and Manifestations in Omani Patients With Sickle Cell Disease
• Date of first enrolment: September 2015
• Target sample size: 280
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT02525107
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Oman

Contacts

• Name: Salam Alkindi, MD

• Name: Salam Alkindi, MD, FRCPI

Key inclusion & exclusion criteria

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.



Age minimum: 13 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Sickle Cell Disease

Intervention(s)

Dietary Supplement: Omega-3 capsules

Dietary Supplement: Placebo

Primary Outcome(s)

Frequency of VOC [Time Frame: 52 weeks]

Duration of Hospitalization [Time Frame: 52 weeks]

Severity of VOC [Time Frame: 52 weeks]

Secondary Outcome(s)

Red blood cells membrane fatty acids profile [Time Frame: 52 weeks]

Secondary ID(s)

ORG/HSS/14/013

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

London Metropolitian University

Ministry of Health, Sultanate of Oman