NCT02525107

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\[SCD\].

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
280

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2015

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 17, 2015

Completed
15 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

August 17, 2015

Status Verified

August 1, 2015

Enrollment Period

3.3 years

First QC Date

August 12, 2015

Last Update Submit

August 14, 2015

Conditions

Sickle Cell Disease

Keywords

Prevention of Vaso Occlusive Painful Crisis

Outcome Measures

Primary Outcomes (3)

  • Frequency of VOC

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

    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

    52 weeks

  • Duration of Hospitalization

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

    52 weeks

Secondary Outcomes (1)

  • Red blood cells membrane fatty acids profile

    52 weeks

Study Arms (2)

SCD patients on Hydroxyurea

EXPERIMENTAL

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 capsulesDietary Supplement: Placebo

SCD patients not on Hydroxyurea

EXPERIMENTAL

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 capsulesDietary Supplement: Placebo

Interventions

Omega-3 capsulesDIETARY_SUPPLEMENT

SCD patients on Hydroxyurea

Also known as: Omega-3 Fatty acid, fish oil supplement
SCD patients on Hydroxyurea
PlaceboDIETARY_SUPPLEMENT

SCD patients on Hydroxyurea

SCD patients on Hydroxyurea

Eligibility Criteria

Age13 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Haematology, Sultan Qaboos University

Muscat, 123, Oman

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Docosahexaenoic AcidsFatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Central Study Contacts

Salam Alkindi, MD, FRCPI

CONTACT

+968-99353188sskindi@squ.edu.om;sskindi@yahoo.com

Anil Pathare, MD,PhD

CONTACT

+968-99384951pathare@squ.edu.om;avp16@hotmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor & Head, Department of Haematology

Study Record Dates

First Submitted

August 12, 2015

First Posted

August 17, 2015

Study Start

September 1, 2015

Primary Completion

January 1, 2019

Study Completion

March 1, 2019

Last Updated

August 17, 2015

Record last verified: 2015-08

Locations

OM(1)