Helminth Infection During Pregnancy on Vitamin D Regulation: HELMVIT Study

Centre de Recherche Médicale de Lambaréné

Status: Completed

Conditions: Vitamin D Deficiency; Immunosuppression

Treatments: Diagnostic Test: Microscopy (Kato Katz, Coproculture, Harada Mori, MIF), qPCR,; Diagnostic Test: Microscopy ( Urine filtration), UCAA test, qPCR,

Study type: Observational

Funder types: Other

Identifiers

NCT04324853

PROT N°038/2018/SG/CNE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

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

Trial design

180 participants in 3 patient groups

S. haematobium positive

Description:

Pregnant women infected with Schistosoma hematobium alone

Treatment:

Diagnostic Test: Microscopy ( Urine filtration), UCAA test, qPCR,

geohelminths positive

Description:

pregnant women infected with geohelminths alone

Treatment:

Diagnostic Test: Microscopy (Kato Katz, Coproculture, Harada Mori, MIF), qPCR,

Helminth negative

Description:

Pregnant women free of anyn helminths infection

Treatment:

Diagnostic Test: Microscopy (Kato Katz, Coproculture, Harada Mori, MIF), qPCR,