Clinical trial NCT04324853: Helminth Infection During Pregnancy on Vitamin D Regulation: HELMVIT Study
Official title: Assessing the Effect of Maternal Helminth Infection on Vitamin D Regulation and on the Immune System of the Infant
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D Deficiency
Immunosuppression
Keywords: Pregnancy
Vitamin D
Helminth
Schistosomiasis
Lead sponsor: Centre de Recherche Médicale de Lambaréné
Sponsor class: OTHER
Collaborators: name: Technical University of Munich
name: University Hospital Tuebingen
First posted: 2020-03-27
Enrollment: 180
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Association between Schistosoma and helminth infection and Vitamin D levels.
timeFrame: 48 Months
Secondary outcomes:
measure: Association between Schistosoma infection and intrauterine growth restriction (IUGR) (defined as birth weight below the 10th birth weight percentile), stillbirth and premature delivery.
timeFrame: 48 Months
Other outcomes:
Locations:
city: Lambaréné
country: Gabon
facility: Josiane Y Honkpehedji
state: Moyen Ogooué
Study officials:
affiliation: Centre de Recherche Médicale de Lambaréné
name: Ayola A ADEGNIKA, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Tuebingen
name: Meral Esen, MD
role: STUDY_CHAIR
affiliation: Technical University of Munich
name: Clarissa DaCosta, MD
role: STUDY_DIRECTOR
References: