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

Primary Purpose

Sickle Cell Disease

Status

Unknown status

Phase

Phase 3

Locations

Oman

Study Type

Interventional

Intervention

Omega-3 capsules

Placebo

Omega-3 capsules

Placebo

About this trial

This is an interventional treatment trial for Sickle Cell Disease focused on measuring Prevention of Vaso Occlusive Painful Crisis

Eligibility Criteria

13 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Department of Haematology, Sultan Qaboos University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

SCD patients on Hydroxyurea

SCD patients not on Hydroxyurea

Arm Description

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: Placebo [730 mg], 4 capsules a day for 52 weeks.[Each capsule will contain 538.2mg Oleic Acid [OA] and 1000 IU Vitamin E]

Outcomes

Primary Outcome Measures

Frequency of VOC

Reduction of the number of Emergency and Hospital visits for VOC episodes compared to the previous 52 weeks

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

Duration of Hospitalization

Reduction in the number of days in hospital with VOC pain compared to the previous 52 weeks

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT02525107

First Posted

August 12, 2015

Last Updated

August 14, 2015

Sponsor

Sultan Qaboos University

Collaborators

Ministry of Health, Sultanate of Oman, London Metropolitian University

1. Study Identification

Unique Protocol Identification Number

NCT02525107

Brief Title

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

Acronym

OM3FA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Unknown status

Study Start Date

September 2015 (undefined)

Primary Completion Date

January 2019 (Anticipated)

Study Completion Date

March 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sultan Qaboos University

Collaborators

Ministry of Health, Sultanate of Oman, London Metropolitian University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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].

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sickle Cell Disease

Keywords

Prevention of Vaso Occlusive Painful Crisis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SCD patients on Hydroxyurea

Arm Type

Experimental

Arm Description

Arm Title

SCD patients not on Hydroxyurea

Arm Type

Experimental

Arm Description

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]

Intervention Type

Dietary Supplement

Intervention Name(s)

Omega-3 capsules

Other Intervention Name(s)

Omega-3 Fatty acid, fish oil supplement

Intervention Description

SCD patients on Hydroxyurea

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

SCD patients on Hydroxyurea

Intervention Type

Dietary Supplement

Intervention Name(s)

Omega-3 capsules

Other Intervention Name(s)

Omega-3 Fatty acid, fish oil supplement

Intervention Description

SCD patients not on Hydroxyurea

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

SCD patients not on Hydroxyurea

Primary Outcome Measure Information:

Title

Frequency of VOC

Description

Reduction of the number of Emergency and Hospital visits for VOC episodes compared to the previous 52 weeks

Time Frame

52 weeks

Title

Severity of VOC

Description

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

Time Frame

52 weeks

Title

Duration of Hospitalization

Description

Reduction in the number of days in hospital with VOC pain compared to the previous 52 weeks

Time Frame

52 weeks

Secondary Outcome Measure Information:

Title

Red blood cells membrane fatty acids profile

Description

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

Time Frame

52 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Salam Alkindi, MD, FRCPI

Phone

+968-99353188

sskindi@squ.edu.om;sskindi@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Anil Pathare, MD,PhD

Phone

+968-99384951

pathare@squ.edu.om;avp16@hotmail.com

Facility Information:

Facility Name

Department of Haematology, Sultan Qaboos University

City

Muscat

ZIP/Postal Code

123

Country

Oman

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Salam Alkindi, MD

Phone

+96824144947

Ext

4947

sskindi@yahoo.com

12. IPD Sharing Statement

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

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