OMEGA-3-FATTY ACIDS IN CHILDREN WITH SICKLE CELL DISEASE
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Flaxseed.
- Who it may be relevant to
- Registry conditions: Sickle Cell Disease (SCD). Basic parameters: 5 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Single Arm/ Open Label Feasibility Trial of Omega-3- Fatty Acids in Children With Sickle Cell Disease
Overview
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.
Interventions
- Dietary supplement Flaxseed
Flaxseed
Primary outcome measures
- Feasibility [Time frame: 4 weeks]
Secondary outcome measures (1)
- Pain [Time frame: 4 weeks]
Eligibility criteria
Inclusion criteria
\- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
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. PMID 36904244
- Osunkwo 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. PMID 33275672
- Raphael 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. PMID 21584938
- Lubeck 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. PMID 31730182
Identifiers
NCT: NCT07530965 · IRB-300016247 · UAB