Helminth Infection During Pregnancy on Vitamin D Regulation: HELMVIT Study (HELMVIT)

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

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency; Immunosuppression
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 180

Contacts and Locations

Study Locations

• Gabon
  • Moyen Ogooué
    • Lambaréné, Moyen Ogooué, Gabon, BP 242
      • Josiane Y Honkpehedji

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

The target population is pregnant women coming to the ante natal clinics (ANC) for routine visits or to obtain medical care in the obstetrics department of the Albert Schweitzer Hospital (ASH) as well as at Georges Rawiri General Hospital (GRGH), both situated in Lambaréné. The pregnant women originally from areas endemic for Schistosomiasis and Soil-transmitted helminths will be invited to participate into the study.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.
S. haematobium positive; Pregnant women infected with Schistosoma 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 geohelminths 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between Schistosoma and helminth infection and Vitamin D levels.	Schistosoma hematobium in pregnancy is associated with vitamin D metabolism	48 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between Schistosoma infection and intrauterine growth restriction (IUGR) (defined as birth weight below the 10th birth weight percentile), stillbirth and premature delivery.	Schistosoma hematobium infection during pregnancy is associated with a birth weight born child	48 Months

Collaborators and Investigators

• Sponsor: Centre de Recherche Médicale de Lambaréné
• Collaborators: University Hospital Tuebingen; Technical University of Munich
• 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, Technical University of Munich

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2019
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: March 25, 2020
• First Submitted That Met QC Criteria: March 26, 2020
• First Posted (Actual): March 27, 2020

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 16, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Vitamin D; Pregnancy; Schistosomiasis; Helminth
• Additional Relevant MeSH Terms: Infections; Nutrition Disorders; Parasitic Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Helminthiasis
• Other Study ID Numbers: PROT N°038/2018/SG/CNE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No