Prevention of Vaso-occlusive Painful Crisis by Using Omega-3 Fatty Acid Supplements
NCT ID: NCT02525107
Last Updated: 2015-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
280 participants
INTERVENTIONAL
2015-09-30
2019-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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\]
Omega-3 capsules
SCD patients on Hydroxyurea
Placebo
SCD patients on Hydroxyurea
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\]
Omega-3 capsules
SCD patients not on Hydroxyurea
Placebo
SCD patients not on Hydroxyurea
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
13 Years
70 Years
ALL
No
Sponsors
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Ministry of Health, Sultanate of Oman
UNKNOWN
London Metropolitian University
UNKNOWN
Sultan Qaboos University
OTHER
Responsible Party
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Salam Alkindi
Professor & Head, Department of Haematology
Locations
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Department of Haematology, Sultan Qaboos University
Muscat, , Oman
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ORG/HSS/14/013
Identifier Type: -
Identifier Source: org_study_id
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