NCT04324853

Helminth Infection During Pregnancy on Vitamin D Regulation: HELMVIT Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 180 (actual)
• Sponsor: Centre de Recherche Médicale de Lambaréné · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Vitamin D Deficiency
• Immunosuppression

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Microscopy ( Urine filtration), UCAA test, qPCR,	Schistosomiasis is an acute and chronic parasitic disease caused by blood flukes (trematode worms) of the genus Schistosoma.Schistosomiasis is prevalent in tropical and subtropical areas, especially in poor communities without access to safe drinking water and adequate sanitation.
DIAGNOSTIC_TEST	Microscopy (Kato Katz, Coproculture, Harada Mori, MIF), qPCR,	Soil-transmitted helminth infections are among the most common infections worldwide and affect the poorest and most deprived communities. They are transmitted by eggs present in human faeces which in turn contaminate soil in areas where sanitation is poor.

Timeline

• Start date: 2019-01-28
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2020-03-27
• Last updated: 2023-06-18

Locations

1 site across 1 country: Gabon