An Observational Trial Designed to Elucidate the Pathways by Which Inflammation Contributes to Anaemia in Sick Rural African Children From 6 Months to 36 Months
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in Serum hepcidin from baseline to day 14
研究概览
简要总结
The Investigator have previously shown that hepcidin is up-regulated even by low levels of inflammation and, according to our prior stable isotope studies, is predicted to block iron absorption. In this follow-up observational study, the investigator aim to characterise the relationship between infections, acute inflammation, hepcidin and iron iron deficiency anaemia in rural African children. The Investigator will study 200 sick children (6-36 months of age) living in the rural region of West Kiang.
The Investigator will:
- Recruit 50 sick febrile children in each of 4 categories; Upper Respiratory tract infections, Lower respiratory tract infections (pneumonia), Urinary tract infections, gastroenteritis.
- Assess iron absorption and its relationship to iron and anaemia status, inflammation, EPO, erythroferrone and hepcidin.
详细描述
Aim 1: To test whether non-malarial infections increase hepcidin levels and for how long in sick children (note that the investigator exclude malaria because the investigator and others have previously examined the effect of malaria).
Hypothesis 1: On day 0, 3 and 7 of acute illness, hepcidin will be higher when compared to levels in well children. On Day 14 iron absorption and hepcidin levels will have returned to baseline.
Research Question 1: What affect do non-malarial infections (upper respiratory tract infections, lower respiratory tract infections, urinary tract infections and gastroenteritis) have on hepcidin levels and how long does this effect last?
Aim 2: To retest our existing hepcidin threshold for discriminating iron absorbers from non-absorbers by repeating our prior ROC analysis based on a much larger sample.
Hypothesis: On day 0, 3 and 7 of acute illness, iron absorption will be lower. On Day 14, iron absorption will be equivalent to iron absorption in well children. Note that the Hepcidin levels and iron absorption data obtained in this study will be compared with the results obtained from similarly aged children in IDeA Study 1 (SCC 1664). Also note that The investigator anticipate that most of the children enrolled in this study will have a base-line level of anaemia (eg Hgb<11g/dL).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female children ages 6-36 months
- •Fever ( > 37.5C) and/or signs of illness.
- •Signed or fingerprinted or personally marked written informed consent obtained from their parent/guardian.
- •Parent/guardian plans for subject to reside in study site area and are able and willing to adhere to all protocol visits and procedures.
排除标准
- •Critically unwell requiring stabilisation and transfer i.e. scores 3 on initial assessment
- •Sickle cell disease
- •Evidence of hookworm infection by stool microscopy
- •Administration of immunosuppressants or other immune-modifying agents within 90 days prior to study IP administration (e.g., systemic corticosteroids at doses equivalent to ≥ 0.5 mg/kg/day of prednisone for more than 14 days; topical steroids including inhaled and intranasal steroids are not exclusionary).
- •Administration of systemic antibiotic treatment within 3 days prior to study enrolment.
- •Any history of or evidence for chronic clinically significant (as per investigator assessment) disorder or disease (including, but not limited to, immunodeficiency, autoimmunity, malnutrition*, congenital abnormality, bleeding disorder, and pulmonary, cardiovascular, metabolic, neurologic, renal, or hepatic disease). * Other than the exclusionary clinical diagnosis of malnutrition for all subjects, in children 2 to 5 years of age, malnutrition is also defined as a weight-for-height Z-score of less than -3 as per WHO reference standards.
- •Any history of human immunodeficiency virus, chronic hepatitis B or chronic hepatitis C infections.
- •Any condition that in the opinion of the investigator might compromise the safety or well-being of the subject or compromise adherence to protocol procedures
- •Participation in another MRC study
结局指标
主要结局
Change in Serum hepcidin from baseline to day 14
时间窗: Day 14
Change in Clinical score of site and severity of infection and inflammation from baseline to day 14
时间窗: Day 14
次要结局
- serum iron levels(Day 0, 3, 7 & 14)
- Erythroferrone(Day 0, 3, 7 & 14)
- Erythropoietin(Day 0, 3, 7 & 14)