Helminth Infection During Pregnancy on Vitamin D Regulation: HELMVIT Study

NCT04324853 | Completed

• 1 other identifier: PROT N°038/2018/SG/CNE
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency; Immunosuppression

Keywords

Pregnancy; Vitamin D; Helminth; Schistosomiasis

Outcome Measures

Primary Outcomes (1)

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

  Schistosoma hematobium in pregnancy is associated with vitamin D metabolism

  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.

  48 Months

Study Arms (3)

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

Microscopy ( Urine filtration), UCAA test, qPCR, DIAGNOSTIC_TEST

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.

S. haematobium positive

Microscopy (Kato Katz, Coproculture, Harada Mori, MIF), qPCR, DIAGNOSTIC_TEST

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; geohelminths positive

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Centre de Recherche Médicale de Lambaréné: lead
• Technical University of Munich: collaborator
• University Hospital Tuebingen: collaborator

Study Sites (1)

Josiane Y Honkpehedji

Lambaréné, Moyen-Ogooué Province, BP 242, Gabon

Location

Biospecimen

Retention: SAMPLES WITH DNA

S. haematobium will be assessed using urine filtration technique, intestinal parasites will be determined using the Kato-Katz method as well as different culture methods According to their infection status, women will be allocated to the following groups: S. haematobium positive, geohelminths positive and helminth negative participants. Plasma and peripheral blood mononuclear cells (PBMCs) are prepared and stored at -150°C; serum will be collected and immediately frozen in lightproof vials at -80 °C until further analysis.

MeSH Terms

Conditions

Vitamin D Deficiency; Schistosomiasis

Interventions

Microscopy

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Trematode Infections; Helminthiasis; Parasitic Diseases; Infections; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Ayola A ADEGNIKA, MD, PhD

  Centre de Recherche Médicale de Lambaréné

  PRINCIPAL INVESTIGATOR

• Meral Esen, MD

  University Hospital Tuebingen

  STUDY CHAIR

• Clarissa DaCosta, MD

  Technical University of Munich

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: March 27, 2020
• Study Start: January 28, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: June 18, 2023

Record last verified: 2023-04

Locations

GA (1)