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Completed

NCT Number: NCT04324853

Helminth Infection During Pregnancy on Vitamin D Regulation: HELMVIT Study

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.

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

Josiane Y Honkpehedji

Lambaréné, Moyen-Ogooué Province, BP 242, Gabon

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Microscopy ( Urine filtration), UCAA test, qPCR,

Diagnostic Test

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.

Microscopy (Kato Katz, Coproculture, Harada Mori, MIF), qPCR,

Diagnostic Test

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.

Primary outcomes

  1. Association between Schistosoma and helminth infection and Vitamin D levels.

    Time frame: 48 Months

    Schistosoma hematobium in pregnancy is associated with vitamin D metabolism

Secondary outcomes

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

    Time frame: 48 Months

    Schistosoma hematobium infection during pregnancy is associated with a birth weight born child

Sponsors and collaborators

Lead sponsor

Centre de Recherche Médicale de Lambaréné

Other

Collaborators

  • Technical University of Munich
  • University Hospital Tuebingen

Registry information

Official study title

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

Acronym: HELMVIT

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 27, 2020
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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