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临床试验/NCT04324853
NCT04324853已完成不适用

Assessing the Effect of Maternal Helminth Infection on Vitamin D Regulation and on the Immune System of the Infant

Centre de Recherche Médicale de Lambaréné1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2019年1月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
180
试验地点
1
主要终点
Association between Schistosoma and helminth infection and Vitamin D levels.

研究概览

简要总结

Purpose: To examine whether helminth infection during pregnancy alters Vitamin-D-metabolism and reactivity of the child's immune system

Hypothesis: Helminth infection during pregnancy is associated with altered Vitamin D levels and Vitamin D receptor expression in the placenta and modified immune reactivity in the infant.

详细描述

Objectives The primary objective of the proposed research project is to study the impact of helminth infection in general and particularly of infection with S. haematobium during pregnancy on Vitamin D metabolism and its related factors as well as the impact of maternal infection on infants developing immune system and health.

Specific Objectives To assess the effect of maternal helminths infections on Vitamin D and vitamin-D-related factors in the serum of pregnant women and cord blood of their infants,

To assess the effect of helminth infection on placental biology:

Determine expression levels of VDR and inflammatory genes Investigate histologically the gestational age and other functional aspects of the placenta Determine the influence of helminth driven inflammation and helminth antigens on placental tissue by establishing a (co-)culture system using primary placental cells and a placental cell line To assess whether helminth infections influence the infant's peripheral immune system by analyzing composition, reactivity and lineage determination of fetal cord blood mononuclear cells (CBMCs) in relation to the maternal and fetal immune and Vitamin D status.

Current study focusing objectives In the present study the investigators explore if and how Vitamin D and its related signals are modulated by helminth infection and how helminth infection could thereby shape the developing immune system of the newborn by analyzing CBMCs.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Pregnant women attending antenatal care from Lambaréné and Fougamou areas
  • Pregnant women who have given written informed consent to the study for herself and for her unborn child and live infant.

排除标准

  • Known of chronic infections and diseases(e.g. diabetes, HIV, Hepatitis B and C, anemia).

结局指标

主要结局

Association between Schistosoma and helminth infection and Vitamin D levels.

时间窗: 48 Months

Schistosoma hematobium in pregnancy is associated with vitamin D metabolism

次要结局

  • Association between Schistosoma infection and intrauterine growth restriction (IUGR) (defined as birth weight below the 10th birth weight percentile), stillbirth and premature delivery.(48 Months)

研究者

发起方
Centre de Recherche Médicale de Lambaréné
申办方类型
Other
责任方
Sponsor

研究点 (1)

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