Helminth Infection During Pregnancy on Vitamin D Regulation: HELMVIT Study

Sponsor

Centre de Recherche Médicale de Lambaréné (Other)

Overall Status

Recruiting

CT.gov ID

NCT04324853

Collaborator

Technische Universität München (Other), University Hospital Tuebingen (Other)

180

Enrollment

Location

47.1

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vitamin D Deficiency Immunosuppression	Diagnostic Test: Microscopy ( Urine filtration), UCAA test, qPCR, Diagnostic Test: Microscopy (Kato Katz, Coproculture, Harada Mori, MIF), qPCR,

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

180 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 28, 2019

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
S. haematobium positive Preganant women infected with Schistosomia hematobium alone	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.
geohelminths positive pregnant women infected with geohlminths alone	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.
Helminth negative Pregnant women free of anyn helminths infection	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.

Arm

Intervention/Treatment

S. haematobium positive

Preganant women infected with Schistosomia hematobium alone

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.

geohelminths positive

pregnant women infected with geohlminths alone

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.

Helminth negative

Pregnant women free of anyn helminths infection

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

Outcome Measures

Primary Outcome Measures

Association between Schistosoma and helminth infection and Vitamin D levels. [48 Months]
Schistosoma hematobium in preganancy is associated with vitamin D metabolism

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Josiane Y Honkpehedji	Lambaréné	Moyen Ogooué	Gabon	BP 242

Sponsors and Collaborators

Centre de Recherche Médicale de Lambaréné
Technische Universität München
University Hospital Tuebingen

Investigators

Principal Investigator: Ayola A ADEGNIKA, MD, PhD, Centre de Recherche Médicale de Lambaréné
Study Chair: Meral Esen, MD, University Hospital Tuebingen
Study Director: Clarissa DaCosta, MD, Technische Universität München