Skip to content

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04324853
Acronym
HELMVIT
Enrollment
180
Registered
2020-03-27
Start date
2019-01-28
Completion date
2022-12-31
Last updated
2023-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunosuppression, Vitamin D Deficiency

Keywords

Pregnancy, Vitamin D, Helminth, Schistosomiasis

Brief 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.

Interventions

DIAGNOSTIC_TESTMicroscopy ( 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_TESTMicroscopy (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.

Sponsors

Technical University of Munich
CollaboratorOTHER
University Hospital Tuebingen
CollaboratorOTHER
Centre de Recherche Médicale de Lambaréné
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Association between Schistosoma and helminth infection and Vitamin D levels.48 MonthsSchistosoma hematobium in pregnancy is associated with vitamin D metabolism

Secondary

MeasureTime frameDescription
Association between Schistosoma infection and intrauterine growth restriction (IUGR) (defined as birth weight below the 10th birth weight percentile), stillbirth and premature delivery.48 MonthsSchistosoma hematobium infection during pregnancy is associated with a birth weight born child

Countries

Gabon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026