Sickle Cell DiseasePhase 3OM3FANCT02525107
Prevention of Vaso-occlusive Painful Crisis by Using Omega-3 Fatty Acid Supplements
A Phase 3 study testing Omega-3 capsules in people with Sickle Cell Disease, run by Sultan Qaboos University at 1 site in Oman.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 70 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Omega-3 capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 1 siteOman
- Study dates
- Sep 2015to Mar 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Oman1 site
Department of Haematology, Sultan Qaboos University
Muscat, 123
Salam Alkindi, MD, +96824144947 ext. 4947, sskindi@yahoo.com
About this study
Official title: Omega 3 Fatty Acid Therapy for Prevention of Vaso-occlusive Crisis and Manifestations in Omani Patients With Sickle Cell Disease
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].
- Conditions
- Sickle Cell Disease
- Being tested
- Omega-3 capsules, Placebo
- Keywords
- Prevention of Vaso Occlusive Painful Crisis
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 capsulesDietary supplement
Also called Omega-3 Fatty acid, fish oil supplement
SCD patients on Hydroxyurea
PlaceboDietary supplement
SCD patients on Hydroxyurea
Omega-3 capsulesDietary supplement
Also called Omega-3 Fatty acid, fish oil supplement
SCD patients not on Hydroxyurea
PlaceboDietary supplement
SCD patients not on Hydroxyurea
| Study group | Role | What they receive |
|---|---|---|
| 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] Receives: Dietary Supplement: Omega-3 capsules; Dietary 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] Receives: Dietary Supplement: Omega-3 capsules; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of VOC
Reduction of the number of Emergency and Hospital visits for VOC episodes compared to the previous 52 weeks
Measured: 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
Measured: 52 weeks
Duration of Hospitalization
Reduction in the number of days in hospital with VOC pain compared to the previous 52 weeks
Measured: 52 weeks
Secondary outcomes (1)
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.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionJan 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Qaboos University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Sultanate of Oman, London Metropolitian University
- Responsible party
- Principal investigator, Salam Alkindi, Sultan Qaboos University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02525107
- Sponsor's protocol ID
- ORG/HSS/14/013
- Acronym
- OM3FA
- Status last verified
- Aug 2015
- First submitted
- 12 Aug 2015
- Last updated
- 17 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega 3 Fatty Acid Therapy for Prevention of Vaso-occlusive Crisis and Manifestations in Omani Patients With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT02525107
- Acronym / sponsor ID
- OM3FA / ORG/HSS/14/013
- Conditions
- Sickle Cell Disease
- Keywords
- Prevention of Vaso Occlusive Painful Crisis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Sultan Qaboos UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health, Sultanate of Oman, London Metropolitian University
- Study start
- Sep 2015
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 17 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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].
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCD patients on Hydroxyurea | Experimental | Dietary Supplement: Omega-3 capsules, Dietary Supplement: PlaceboOmega-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] |
| SCD patients not on Hydroxyurea | Experimental | Dietary Supplement: Omega-3 capsules, Dietary Supplement: PlaceboDietary 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] |
Who may qualify
- Ages
- 13 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 capsulesAlso: Omega-3 Fatty acid, fish oil supplementSCD patients on Hydroxyurea | Dietary supplement | SCD patients on Hydroxyurea |
| PlaceboSCD patients on Hydroxyurea | Dietary supplement | SCD patients on Hydroxyurea |
| Omega-3 capsulesAlso: Omega-3 Fatty acid, fish oil supplementSCD patients not on Hydroxyurea | Dietary supplement | SCD patients not on Hydroxyurea |
| PlaceboSCD patients not on Hydroxyurea | Dietary supplement | SCD patients not on Hydroxyurea |
Primary outcome
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
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
Duration of Hospitalization
Time frame: 52 weeks
Reduction in the number of days in hospital with VOC pain compared to the previous 52 weeks
1 secondary outcome
Red blood cells membrane fatty acids profile
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Omega-3 capsules in people with Sickle Cell Disease, run by Sultan Qaboos University at 1 site in Oman.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Oman. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Salam Alkindi, MD, FRCPI (+968-99353188, sskindi@squ.edu.om;sskindi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of VOC (time frame: 52 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2015.