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

NCT ID: NCT02525107

Last Updated: 2015-08-17

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2019-03-31

Brief Summary

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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

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Conditions

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Sickle Cell Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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\]

Group Type EXPERIMENTAL

Omega-3 capsules

Intervention Type DIETARY_SUPPLEMENT

SCD patients on Hydroxyurea

Placebo

Intervention Type DIETARY_SUPPLEMENT

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\]

Group Type EXPERIMENTAL

Omega-3 capsules

Intervention Type DIETARY_SUPPLEMENT

SCD patients not on Hydroxyurea

Placebo

Intervention Type DIETARY_SUPPLEMENT

SCD patients not on Hydroxyurea

Interventions

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Omega-3 capsules

SCD patients on Hydroxyurea

Intervention Type DIETARY_SUPPLEMENT

Placebo

SCD patients on Hydroxyurea

Intervention Type DIETARY_SUPPLEMENT

Omega-3 capsules

SCD patients not on Hydroxyurea

Intervention Type DIETARY_SUPPLEMENT

Placebo

SCD patients not on Hydroxyurea

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Omega-3 Fatty acid, fish oil supplement Omega-3 Fatty acid, fish oil supplement

Eligibility Criteria

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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.
Minimum Eligible Age

13 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Sultanate of Oman

UNKNOWN

Sponsor Role collaborator

London Metropolitian University

UNKNOWN

Sponsor Role collaborator

Sultan Qaboos University

OTHER

Sponsor Role lead

Responsible Party

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Salam Alkindi

Professor & Head, Department of Haematology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Haematology, Sultan Qaboos University

Muscat, , Oman

Site Status

Countries

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Oman

Central Contacts

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Salam Alkindi, MD, FRCPI

Role: CONTACT

Anil Pathare, MD,PhD

Role: CONTACT

Facility Contacts

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Salam Alkindi, MD

Role: primary

+96824144947 ext. 4947

Other Identifiers

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ORG/HSS/14/013

Identifier Type: -

Identifier Source: org_study_id

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