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

• ClinicalTrials.gov Identifier: NCT02525107
• Recruitment Status: Unknown
• First Posted: August 17, 2015
• Last Update Posted: August 17, 2015
• Sponsor: Sultan Qaboos University
• Collaborators: Ministry of Health, Sultanate of Oman; London Metropolitian University
• Information provided by (Responsible Party): Salam Alkindi, Sultan Qaboos University

Tracking Information

• First Submitted Date: August 12, 2015
• First Posted Date: August 17, 2015
• Last Update Posted Date: August 17, 2015
• Study Start Date: September 2015
• Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 14, 2015)

• Frequency of VOC [ Time Frame: 52 weeks ]
  Reduction of the number of Emergency and Hospital visits for VOC episodes compared to the previous 52 weeks
• Severity of VOC [ Time Frame: 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 [ Time Frame: 52 weeks ]
  Reduction in the number of days in hospital with VOC pain compared to the previous 52 weeks

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: August 14, 2015)

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

Measurement of red blood cell membrane ethanolamine phosphoglyceride[DHA, EPA, AA] at baseline and after 52 weeks intervention period.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Prevention of Vaso-occlusive Painful Crisis by Using Omega-3 Fatty Acid Supplements
• Official Title: Omega 3 Fatty Acid Therapy for Prevention of Vaso-occlusive Crisis and Manifestations in Omani Patients With Sickle Cell Disease
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Sickle Cell Disease

Intervention

• Dietary Supplement: Omega-3 capsules
  SCD patients on Hydroxyurea
  Other Name: 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 Name: Omega-3 Fatty acid, fish oil supplement
• Dietary Supplement: Placebo
  SCD patients not on Hydroxyurea

Study Arms

• 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]
  Interventions:

  • Dietary Supplement: Omega-3 capsules
  • Dietary Supplement: Placebo
• 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]
  Interventions:

  • Dietary Supplement: Omega-3 capsules
  • Dietary Supplement: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: August 14, 2015): 280
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 2019
• Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 13 Years to 70 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Oman

Administrative Information

• NCT Number: NCT02525107
• Other Study ID Numbers: ORG/HSS/14/013
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Salam Alkindi, Sultan Qaboos University
• Original Responsible Party: Same as current
• Current Study Sponsor: Sultan Qaboos University
• Original Study Sponsor: Same as current

Collaborators

• Ministry of Health, Sultanate of Oman
• London Metropolitian University

• Investigators: Not Provided
• PRS Account: Sultan Qaboos University
• Verification Date: August 2015