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

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ClinicalTrials.gov Identifier: NCT02525107
Recruitment Status : Unknown
Verified August 2015 by Salam Alkindi, Sultan Qaboos University.
Recruitment status was:  Not yet recruiting
First Posted : August 17, 2015
Last Update Posted : August 17, 2015
Sponsor:
Collaborators:
Ministry of Health, Sultanate of Oman
London Metropolitian University
Information provided by (Responsible Party):
Salam Alkindi, Sultan Qaboos University

Study Description
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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].

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Dietary Supplement: Omega-3 capsules Dietary Supplement: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Omega 3 Fatty Acid Therapy for Prevention of Vaso-occlusive Crisis and Manifestations in Omani Patients With Sickle Cell Disease
Study Start Date : September 2015
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Omega-3 Fatty acid, fish oil supplement

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

Dietary Supplement: Placebo
SCD patients not on Hydroxyurea


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. Duration of Hospitalization [ Time Frame: 52 weeks ]
    Reduction in the number of days in hospital with VOC pain compared to the previous 52 weeks


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   13 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02525107


Contacts
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Contact: Salam Alkindi, MD, FRCPI +968-99353188 sskindi@squ.edu.om;sskindi@yahoo.com
Contact: Anil Pathare, MD,PhD +968-99384951 pathare@squ.edu.om;avp16@hotmail.com

Locations
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Oman
Department of Haematology, Sultan Qaboos University
Muscat, Oman, 123
Contact: Salam Alkindi, MD    +96824144947 ext 4947    sskindi@yahoo.com   
Sponsors and Collaborators
Sultan Qaboos University
Ministry of Health, Sultanate of Oman
London Metropolitian University
More Information
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Responsible Party: Salam Alkindi, Professor & Head, Department of Haematology, Sultan Qaboos University
ClinicalTrials.gov Identifier: NCT02525107    
Other Study ID Numbers: ORG/HSS/14/013
First Posted: August 17, 2015    Key Record Dates
Last Update Posted: August 17, 2015
Last Verified: August 2015
Keywords provided by Salam Alkindi, Sultan Qaboos University:
Prevention of Vaso Occlusive Painful Crisis
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn