Efficacy of Gum Arabic as Anti-oxidant, Anti-inflammatory and Fetal Hemoglobin Inducing Agent in Sickle Cell Anemia Patients : A Randomized, Double-blind, Two-armed Parallel-group, Placebo-controlled Phase II/III Study - Khartoum, Sudan
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Total anti oxidant capacity
研究概览
简要总结
To study the efficacy of Gum Arabic as an anti-oxidant, anti-inflammatory and Fetal Hemoglobin-inducing agent among Sickle Cell Disease children. Half of participants will receive Gum Arabic and the other half will receive placebo
详细描述
Polymerized hemoglobin is injurious to the red cell membrane, resulting in oxidative damage in sickle cell disease . Fetal hemoglobin is protective against sickling and its decrease is associated with vaso-occlusive crisis . Gum Arabic is soluble fibers with prebiotic properties. It increased the level of serum butyrate which is short chain fatty acid. The latter proved to serve as fetal hemoglobin inducing agent both in vivo and in vitro study. And also has strong anti-inflammatory properties. So our aim to test whether oral digestion of Gum Arabic will induce fetal hemoglobin among sickle cell pediatric patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, care providers, Investigator and outcome assessor will be masked regarding the type of intervention each group will receive
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Homozygous for Sickle Cell Disease (SS) as documented by Haemoglobin electrophoresis.
- •Subjects whom medications and dosages had been stable for 2 weeks before study entry.
- •Subjects who have not received blood transfusion or had acute episode related to sickle cell disease in the last two weeks before the start of intervention.
排除标准
- •Patients with history of Gum Arabic allergy. Patients who have ischemic heart disease, liver dysfunction or hepatitis. Pregnant female patients who plan to conceive in the next 4 months and fertile female patients who are not using an effective contraception method.
- •Patients who are currently using Gum Arabic. Patients who are on steroids or chemotherapy.
结局指标
主要结局
Total anti oxidant capacity
时间窗: 12 weeks
Measure increase from the baseline values
Fetal hemoglobin level after 12 weeks
时间窗: 12 weeks
Measure increase from the baseline values
次要结局
- Anti inflammatory marker C reactive Protein(12 weeks)
研究者
Lamis Kaddam
Director
Al-Neelain University