A Feasibility Study on the Use of Plant Based Omega-3-Fatty Acids (Flaxseed) to Improve Inflammation Driven Pain Outcomes in Children With Sickle Cell Anemia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Acute pain
研究概览
简要总结
Sickle cell disease (SCD) is associated with significant morbidity and mortality. Pain and many adverse outcomes occurring in sickle cell disease are 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. Omega -3-fatty acids (fish oil) has been shown to improve pain outcomes in individuals with sickle cell disease, but its acceptance is variable. The aim of this study is to determine if a plant-based omega-3-fatty acids will be more acceptable and also improve outcomes in individuals with sickle cell disease
详细描述
Sickle cell disease (SCD) is associated with significant morbidity and mortality. Pain and many adverse outcomes occurring in sickle cell disease are 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. Omega -3-fatty acids (fish oil) has been shown to improve pain outcomes in individuals with sickle cell disease, but its acceptance is variable. The aim of this study is to determine if a plant-based omega-3-fatty acids will be more acceptable and also improve outcomes in individuals with sickle cell disease.
Children aged 5-18 years will be randomized to receive a diet rich in omega-3-fatty acids versus a regular diet for 12 weeks after which there will be a cross over of arms after a 4-week wash out period. We will compare outcomes (including patient reported pain outcomes and improvement in inflammation markers) while on the omega-3 fatty acid rich diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Both principal investigator and participants will be blinded to arm of study
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of sickle cell anemia HbSS or HbSB0 thal at steady state
- •Age 5-18 years old
排除标准
- •Age less than 5 years
- •Age > 18 years old
- •Chronic transfusion therapy
- •Known to be pregnant
- •Breastfeeding mothers
- •Current use of antibiotics
- •Use of pre or probiotic supplements
- •PPI therapy
- •Known allergy to FS
研究组 & 干预措施
Regular diet
Participants will continue their regular diet.
Plant based omega 3 Fatty Acid
Participants ingest their regular diet supplemented with a plant-based omega-3-FA
干预措施: Plant-based omega-3-FA (Dietary Supplement)
结局指标
主要结局
Acute pain
时间窗: 12 weeks
Decrease in acute pain frequency measured with weekly pain diaries and acute care visits for pain
Chronic pain
时间窗: 12 weeks
Improvement in quality of life measured using a validated questionnaire
次要结局
- Inflammation(12 weeks)
研究者
Chinenye Dike
Assistant Professor of Pediatrics, Division of Pediatric Gastroenterology, Hepatology and Nutrition
University of Alabama at Birmingham