ClinicalTrials.gg
CompletedNCT04324853HELMVITUpdated Jun 18, 2023

Helminth Infection During Pregnancy on Vitamin D Regulation: HELMVIT Study

An observational study in Vitamin D Deficiency and Immunosuppression, sponsored by Centre de Recherche Médicale de Lambaréné. Completed at 1 site in Gabon. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-18.

Sponsored by Centre de Recherche Médicale de Lambaréné · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
180
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Vitamin D Deficiency
  • Immunosuppression

Keywords

  • Pregnancy
  • Vitamin D
  • Helminth
  • Schistosomiasis
03

In context

Vitamin D Deficiency

784 studies on the registry are indexed under Vitamin D Deficiency; 61 are open to participants now.

This study's enrollment of 180 is above the median of 150 across 185 observational studies indexed under Vitamin D Deficiency.

Browse Vitamin D Deficiency studies →

Lead sponsor

Centre de Recherche Médicale de Lambaréné is the lead sponsor of 17 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Known of chronic infections and diseases(e.g. diabetes, HIV, Hepatitis B and C, anemia).
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
180 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • S. haematobium positive

    Pregnant women infected with Schistosoma hematobium alone

    Diagnostic Test: Microscopy ( Urine filtration), UCAA test, qPCR,

  • geohelminths positive

    pregnant women infected with geohelminths alone

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

  • Helminth negative

    Pregnant women free of anyn helminths infection

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

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.

06

What researchers measure

Primary outcomes

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

    Schistosoma hematobium in pregnancy is associated with vitamin D metabolism

    Time frame: 48 Months

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.

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

    Time frame: 48 Months

07

Study locations

1 site
  • Josiane Y Honkpehedji
    Lambaréné, Moyen-Ogooué Province BP 242, Gabon
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04324853
Lead sponsor
Centre de Recherche Médicale de Lambaréné
Responsible party
Sponsor
First posted
Mar 27, 2020
Start date
Jan 28, 2019
Primary completion
Dec 31, 2022
Completion
Dec 31, 2022
Last update
Jun 18, 2023

Study contacts

Ayola A ADEGNIKA, MD, PhD
principal investigator · Centre de Recherche Médicale de Lambaréné
Meral Esen, MD
study chair · University Hospital Tuebingen
Clarissa DaCosta, MD
study director · Technical University of Munich

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion