Helminth Infection During Pregnancy on Vitamin D Regulation: HELMVIT Study
- Conditions
- Vitamin D DeficiencyImmunosuppression
- Interventions
- Diagnostic Test: Microscopy (Kato Katz, Coproculture, Harada Mori, MIF), qPCR,Diagnostic Test: Microscopy ( Urine filtration), UCAA test, qPCR,
- Registration Number
- NCT04324853
- Lead Sponsor
- Centre de Recherche Médicale de Lambaréné
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 180
- 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.
- Known of chronic infections and diseases(e.g. diabetes, HIV, Hepatitis B and C, anemia).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Helminth negative Microscopy (Kato Katz, Coproculture, Harada Mori, MIF), qPCR, Pregnant women free of anyn helminths infection S. haematobium positive Microscopy ( Urine filtration), UCAA test, qPCR, Pregnant women infected with Schistosoma hematobium alone geohelminths positive Microscopy (Kato Katz, Coproculture, Harada Mori, MIF), qPCR, pregnant women infected with geohelminths alone
- Primary Outcome Measures
Name Time Method Association between Schistosoma and helminth infection and Vitamin D levels. 48 Months Schistosoma hematobium in pregnancy is associated with vitamin D metabolism
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Josiane Y Honkpehedji
🇬🇦Lambaréné, Moyen Ogooué, Gabon