Vitamin D DeficiencyHELMVITNCT04324853
Helminth Infection During Pregnancy on Vitamin D Regulation: HELMVIT Study
An observational study of Vitamin D Deficiency and Immunosuppression, run by Centre de Recherche Médicale de Lambaréné at 1 site in Gabon.
Trial 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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Immunosuppression
- What is being tested?
- Microscopy ( Urine filtration), UCAA test, qPCR, and Microscopy (Kato Katz, Coproculture, Harada Mori, MIF), qPCR,
- How many people
- 180 participants
- Where
- 1 siteGabon
- Study dates
- 28 Jan 2019to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Known of chronic infections and diseases(e.g. diabetes, HIV, Hepatitis B and C, anemia).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Vitamin D Deficiency, Immunosuppression
- Being tested
- Microscopy ( Urine filtration), UCAA test, qPCR,, Microscopy (Kato Katz, Coproculture, Harada Mori, MIF), qPCR,
- Keywords
- Pregnancy, Vitamin D, Helminth, Schistosomiasis
- Medical subject headings
- Vitamin D Deficiency, Schistosomiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| S. haematobium positive | Pregnant women infected with Schistosoma hematobium alone Receives: Diagnostic Test: Microscopy ( Urine filtration), UCAA test, qPCR, | |
| geohelminths positive | pregnant women infected with geohelminths alone Receives: Diagnostic Test: Microscopy (Kato Katz, Coproculture, Harada Mori, MIF), qPCR, | |
| Helminth negative | Pregnant women free of anyn helminths infection Receives: Diagnostic Test: Microscopy (Kato Katz, Coproculture, Harada Mori, MIF), qPCR, |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between Schistosoma and helminth infection and Vitamin D levels.
Schistosoma hematobium in pregnancy is associated with vitamin D metabolism
Measured: 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
Measured: 48 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start28 Jan 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche Médicale de Lambaréné
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Munich, University Hospital Tuebingen
- Responsible party
- Sponsor
- Investigators
- Ayola A ADEGNIKA, MD, PhD, Principal investigator, Centre de Recherche Médicale de LambarénéMeral Esen, MD, Study chair, University Hospital TuebingenClarissa DaCosta, MD, Study director, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04324853
- Sponsor's protocol ID
- PROT N°038/2018/SG/CNE
- Acronym
- HELMVIT
- Status last verified
- Apr 2023
- First submitted
- 25 Mar 2020
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effect of Maternal Helminth Infection on Vitamin D Regulation and on the Immune System of the Infant
- ClinicalTrials.gov ID
- NCT04324853
- Acronym / sponsor ID
- HELMVIT / PROT N°038/2018/SG/CNE
- Conditions
- Vitamin D Deficiency, Immunosuppression
- Keywords
- Pregnancy, Vitamin D, Helminth, Schistosomiasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Centre de Recherche Médicale de LambarénéUniversity, hospital or other
- Collaborators
- Technical University of Munich, University Hospital Tuebingen
- Study start
- 28 Jan 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 27 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| S. haematobium positive | – | Diagnostic Test: Microscopy ( Urine filtration), UCAA test, qPCR,Pregnant women infected with Schistosoma hematobium alone |
| geohelminths positive | – | Diagnostic Test: Microscopy (Kato Katz, Coproculture, Harada Mori, MIF), qPCR,pregnant women infected with geohelminths alone |
| Helminth negative | – | Diagnostic Test: Microscopy (Kato Katz, Coproculture, Harada Mori, MIF), qPCR,Pregnant women free of anyn helminths infection |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Known of chronic infections and diseases(e.g. diabetes, HIV, Hepatitis B and C, anemia).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | S. haematobium positive |
| 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. | Diagnostic test | Helminth negative, geohelminths positive |
Primary outcome
Association between Schistosoma and helminth infection and Vitamin D levels.
Time frame: 48 Months
Schistosoma hematobium in pregnancy is associated with vitamin D metabolism
1 secondary outcome
Association between Schistosoma infection and intrauterine growth restriction (IUGR) (defined as birth weight below the 10th birth weight percentile), stillbirth and premature delivery.
Time frame: 48 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
Related trials for Vitamin D Deficiency
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Recruiting
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
RecruitingObservational study
Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients
FGF23-related Hypophosphataemic Rickets and Osteomalacia
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency and Immunosuppression, run by Centre de Recherche Médicale de Lambaréné at 1 site in Gabon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Gabon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between Schistosoma and helminth infection and Vitamin D levels. (time frame: 48 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.