Sickle Cell Disease (SCD)NCT07530965
Omega-3-Fatty Acids in Children With Sickle Cell Disease
A study testing Flaxseed in people with Sickle Cell Disease (SCD), run by University of Alabama at Birmingham.
Trial summary
The purpose of this feasibility study is to investigate the role of a dietary supplement in modulating the gut microbiota and improving pain outcomes in children with sickle cell disease (SCD). Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Sickle Cell Disease (SCD)
- What is being tested?
- Flaxseed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children 5-18 years with SCD at steady state. Steady state will be defined as not requiring an acute care visit for pain in the last 28 days.
Who cannot join
- current use of antibiotics except prophylactic penicillin
- current use of pre-or probiotic supplements
- current use of PPI therapy
- pregnant or lactating females
- individuals with known allergy to Flaxseed
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single Arm/ Open Label Feasibility Trial of Omega-3- Fatty Acids in Children With Sickle Cell Disease
The purpose of this feasibility study is to investigate the role of a dietary supplement in modulating the gut microbiota and improving pain outcomes in children with sickle cell disease (SCD).
Read the detailed description
Sickle cell disease (SCD) is associated with significant morbidity and mortality. Acute pain is the most frequent cause of hospitalization in children. Pain in sickle cell disease is inflammatory driven. Recent data has shown that gut dysbiosis is present in individuals with sickle cell disease. Gut dysbiosis has been linked to inflammation in certain diseases. Our preliminary study showed that gut dysbiosis is linked to pain.
Omega -3-fatty acids (fish oil) has been shown to improve pain outcomes in individuals with SCD. Acceptance of fish oil varies given its fishy smell and taste. Flaxseed is a plant-based omega-3-fatty acid which has antioxidant and anti-inflammatory properties.
This study aims to conduct a feasibility trial on the use of flaxseed to modulating the gut microbiome and improving inflammatory markers and pain outcomes in children with SCD.
- Conditions
- Sickle Cell Disease (SCD)
- Being tested
- Flaxseed
- Keywords
- Nutritional trial, sickle cell disease, children
- 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.
FlaxseedDietary supplement
Flaxseed
| Study group | Role | What they receive |
|---|---|---|
| Flaxseed | Other | Not described Receives: Dietary Supplement: Flaxseed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Participants will be asked to complete electronic adherence dairies- Feasibility will be defined by more than 50% of enrolled participants eating flaxseed at least 5 days a week for the study duration
Measured: 4 weeks
Secondary outcomes (1)
Pain
Patient reported pain outcomes will be assessed weekly with pain scores and end of the study with quality of life measures
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell Disease (SCD)Studies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chinenye Dike, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530965
- Sponsor's protocol ID
- IRB-300016247
- Other IDs
- UAB
- Status last verified
- Apr 2026
- First submitted
- 16 Mar 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dike CR, Lebensburger J, Mitchell C, Darnell B, Morrow CD, Demark-Wahnefried W. Palatability and Acceptability of Flaxseed-Supplemented Foods in Children with Sickle Cell Disease. Nutrients. 2023 Mar 1;15(5):1245. doi: 10.3390/nu15051245.
PubMed 36904244Osunkwo I, O'Connor HF, Saah E. Optimizing the management of chronic pain in sickle cell disease. Hematology Am Soc Hematol Educ Program. 2020 Dec 4;2020(1):562-569. doi: 10.1182/hematology.2020000143.
PubMed 33275672Raphael JL, Mei M, Mueller BU, Giordano T. High resource hospitalizations among children with vaso-occlusive crises in sickle cell disease. Pediatr Blood Cancer. 2012 Apr;58(4):584-90. doi: 10.1002/pbc.23181. Epub 2011 May 16.
PubMed 21584938Lubeck D, Agodoa I, Bhakta N, Danese M, Pappu K, Howard R, Gleeson M, Halperin M, Lanzkron S. Estimated Life Expectancy and Income of Patients With Sickle Cell Disease Compared With Those Without Sickle Cell Disease. JAMA Netw Open. 2019 Nov 1;2(11):e1915374. doi: 10.1001/jamanetworkopen.2019.15374.
PubMed 31730182
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm/ Open Label Feasibility Trial of Omega-3- Fatty Acids in Children With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT07530965
- Acronym / sponsor ID
- IRB-300016247
- Conditions
- Sickle Cell Disease (SCD)
- Keywords
- Nutritional trial, sickle cell disease, children
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 15 Apr 2026 (actual)
- 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.
The purpose of this feasibility study is to investigate the role of a dietary supplement in modulating the gut microbiota and improving pain outcomes in children with sickle cell disease (SCD).
Detailed description
Sickle cell disease (SCD) is associated with significant morbidity and mortality. Acute pain is the most frequent cause of hospitalization in children. Pain in sickle cell disease is inflammatory driven. Recent data has shown that gut dysbiosis is present in individuals with sickle cell disease. Gut dysbiosis has been linked to inflammation in certain diseases. Our preliminary study showed that gut dysbiosis is linked to pain.
Omega -3-fatty acids (fish oil) has been shown to improve pain outcomes in individuals with SCD. Acceptance of fish oil varies given its fishy smell and taste. Flaxseed is a plant-based omega-3-fatty acid which has antioxidant and anti-inflammatory properties.
This study aims to conduct a feasibility trial on the use of flaxseed to modulating the gut microbiome and improving inflammatory markers and pain outcomes in children with SCD.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flaxseed | Other | Dietary Supplement: Flaxseed |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children 5-18 years with SCD at steady state. Steady state will be defined as not requiring an acute care visit for pain in the last 28 days.
Key exclusion criteria (5 listed)
- current use of antibiotics except prophylactic penicillin
- current use of pre-or probiotic supplements
- current use of PPI therapy
- pregnant or lactating females
- individuals with known allergy to Flaxseed
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 |
|---|---|---|
| FlaxseedFlaxseed | Dietary supplement | Flaxseed |
Primary outcome
Feasibility
Time frame: 4 weeks
Participants will be asked to complete electronic adherence dairies- Feasibility will be defined by more than 50% of enrolled participants eating flaxseed at least 5 days a week for the study duration
1 secondary outcome
Pain
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Results publication: PubMed 36904244Dike CR, Lebensburger J, Mitchell C, Darnell B, Morrow CD, Demark-Wahnefried W. Palatability and Acceptability of Flaxseed-Supplemented Foods in Children with Sickle Cell Disease. Nutrients. 2023 Mar 1;15(5):1245. doi: 10.3390/nu15051245.
- Results publication: PubMed 33275672Osunkwo I, O'Connor HF, Saah E. Optimizing the management of chronic pain in sickle cell disease. Hematology Am Soc Hematol Educ Program. 2020 Dec 4;2020(1):562-569. doi: 10.1182/hematology.2020000143.
- Results publication: PubMed 21584938Raphael JL, Mei M, Mueller BU, Giordano T. High resource hospitalizations among children with vaso-occlusive crises in sickle cell disease. Pediatr Blood Cancer. 2012 Apr;58(4):584-90. doi: 10.1002/pbc.23181. Epub 2011 May 16.
- Results publication: PubMed 31730182Lubeck D, Agodoa I, Bhakta N, Danese M, Pappu K, Howard R, Gleeson M, Halperin M, Lanzkron S. Estimated Life Expectancy and Income of Patients With Sickle Cell Disease Compared With Those Without Sickle Cell Disease. JAMA Netw Open. 2019 Nov 1;2(11):e1915374. doi: 10.1001/jamanetworkopen.2019.15374.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Flaxseed in people with Sickle Cell Disease (SCD), run by University of Alabama at Birmingham.
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 1 inclusion and 5 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: opening soon, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chinenye R Dike, MD MS (205 638 9918, cdike@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07530965, which also lists 4 linked publications.
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 21 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.