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

Sickle Cell Disease Clinical Trial

— OM3FA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02525107
• Other study ID #: ORG/HSS/14/013
• Status: Not yet recruiting
• Phase: Phase 3
• First received: August 12, 2015
• Last updated: August 14, 2015
• Start date: September 2015
• Est. completion date: March 2019

Study information

• Verified date: August 2015
• Source: Sultan Qaboos University
• Contact: Salam Alkindi, MD, FRCPI
• Phone: +968-99353188
• Email: sskindi[@]squ.edu.om;sskindi[@]yahoo.com
• Is FDA regulated: No
• Health authority: Sultanate of Oman:The Research Council
• Study type: Interventional

Clinical Trial 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].

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 280
• Est. completion date: March 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Dietary Supplement:
• Omega-3 capsules
SCD patients on Hydroxyurea
• Placebo
SCD patients on Hydroxyurea
• Omega-3 capsules
SCD patients not on Hydroxyurea
• Placebo
SCD patients not on Hydroxyurea

Locations

Country	Name	City	State
Oman	Department of Haematology, Sultan Qaboos University	Muscat

Sponsors (3)

Lead Sponsor	Collaborator
Sultan Qaboos University	London Metropolitian University, Ministry of Health, Sultanate of Oman

Country where clinical trial is conducted

Oman, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of VOC	Reduction of the number of Emergency and Hospital visits for VOC episodes compared to the previous 52 weeks	52 weeks	No
Primary	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	No
Primary	Duration of Hospitalization	Reduction in the number of days in hospital with VOC pain compared to the previous 52 weeks	52 weeks	No
Secondary	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	Yes