An Observational Study Designed to Elucidate the Pathways by Which Low-grade Inflammation Contributes to Anaemia in Rural African Children From 6 Months to 2 Years of Age
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- clinical score of site and severity of infection and inflammation
研究概览
简要总结
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, investigator aim to elucidate the potential drivers of this low-grade inflammation and to recalibrate the relationship between hepcidin and iron absorption using a more direct measure of absorption than the stable isotope method which measures the net of absorption and utilization. Investigator will study 120 ostensibly well children (6-24m) living in the rural region of West Kiang.
Investigator will:
- Use detailed clinical screening for possible origins of the low grade inflammation.
- Assess iron absorption and its relationship to iron and anaemia status, inflammation, EPO, erythroferrone and hepcidin.
详细描述
Aim 1:
Hypothesis 1: 'Minor' but persistent infections of the respiratory tract, skin, mouth, and gut cause chronic elevation of hepcidin levels and other markers of infection including CRP.
Research Question 1: What is the relationship between each of the following: CRP, hepcidin, clinical score of skin infections; clinical score of oral health; clinical score of respiratory infections; and systemic markers of gut damage and bacterial translocation (serum EndoCAB and iFABP) and stool markers of inflammation (calprotectin, REG1b and lipocalin2).
Hypothesis 2: Respiratory infections and airway inflammation are the most common cause of low grade inflammation.
Research Question 2: What is the most common source(s) of persistent low-grade inflammation in apparently well children living in rural Gambia.
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 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female children ages 6-8 months at the time of study enrolment.
- •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
- •Acute illness
- •Fever (for eligibility purpose defined as a body temperature greater than 37.5°C) if appropriate, as per investigator assessment, subject may be re-revaluated for eligibility).
- •Vaccination less than 7 days prior to study enrollment.
- •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).
- •Any history of maternal 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
clinical score of site and severity of infection and inflammation
时间窗: 18 months
Clinical score of skin infections, oral health, eye infections, upper and lower respiratory tract infections. see score below: Clinical score of inflammation and infection Total out of 81 Range 0-81 0= no inflammation/ infection 81= severe multi focal inflammation/infection
Serum hepcidin level
时间窗: 18 months
To examine in detail the pathways by which low-grade inflammation causes iron deficiency anaemia in African children
次要结局
- erythroferrone concentration(18 months)
- concentration of helminths in stool(18 months)
- inflammatory markers(18 months)
- haematology parameters(18 months)
- Stool parameters - parasites concentration(18 months)
- serum transferrin concentration(18 months)
- erythropoietin concentration(18 months)
- lipocalin 2(18 months)
- Iron biomarkers - serum ferritin concentration(18 months)
- Reg1b(18 months)
- iron absorption(18 months)
- total iron binding capacity(18 months)
- soluble transferrin receptor (sTfR)(18 months)
- calprotectin(18 months)