AsthmaREPRO_PLNCT01861548
Polish Mother and Child Cohort Study (REPRO_PL) - Follow up of the Children.
An observational study of Asthma and Atopic Dermatitis, run by Medical University of Lodz at 2 sites in Poland.
Trial summary
The Polish Mother and Child Cohort is multicentre prospective study on different exposures. Prospective cohort study design enables identification of exposures that may influence pregnancy outcome and chil-dren's health, verification of such exposures by biomarker measurements and notification of any changes in… Read more about this study
- Who is it for?
- Ages 1 minute to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Atopic Dermatitis, Food Allergy
- How many people
- 479 participants
- Where
- 2 sitesPoland
- Study dates
- Jan 2007to May 2013
- 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 1 minute to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Investigators include into the study children delivered from women observed starting from between 8-12 weeks of single pregnancy, not assisted with reproductive technology, and not expected to be finished as spontaneous abor-tion. All women with the serious chronic diseases specified in study protocol such as diabetes, hypertension, nephrop-athy, epilepsy and cancer are excluded from the study. The same refers to suspicion of serious child malformations known to exist at the inclusion into the study.
Who may be able to join
- Investigators include into the study children delivered from women observed starting from between 8-12 weeks of single pregnancy, not assisted with reproductive technology, and not expected to be finished as spontaneous abor-tion. All women with the serious chronic diseases specified in study protocol such as diabetes, hypertension, nephrop-athy, epilepsy and cancer are excluded from the study. The same refers to suspicion of serious child malformations known to exist at the inclusion into the study.
Who cannot join
- Serious child malformations known to exist at the inclusion into the study.
- Children delivered from all women with the serious chronic diseases specified in study protocol such as diabetes, hypertension, nephrop-athy, epilepsy and cancer are excluded from the study.
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Nofer Institute of Occupational Medicine, Department of Environmental Epidemiology
Lodz, 91-348
Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital, Lodz, Poland
Lodz, 93-513
About this study
Official title: Polish Mother and Child Cohort Study (REPRO_PL).Follow up of the Children.
The Polish Mother and Child Cohort is multicentre prospective study on different exposures.
Prospective cohort study design enables identification of exposures that may influence pregnancy outcome and chil-dren's health, verification of such exposures by biomarker measurements and notification of any changes in exposure levels.
Read more
The aim of the study is to evaluate the impact of exposure to different environmental factors during pregnancy and after birth on pregnancy outcome and children's health. Specific research hypotheses refer to the role of heavy metals, exposure to polycyclic aromatic hydrocar-bons (PAHs) and environmental tobacco smoke (ETS) in the aetiology of intrauterine growth retardation (IUGR), preterm delivery (PD) and the risk of respiratory diseases, allergy and poor mental and physical development. It is also intended to explain the role of oxidative stress and nutritional status of the pregnant women. The impact of occupational exposures and stressful situations on pregnancy outcome will be evaluated from question-naire data.
The results of the study will help to determine levels of child prenatal and postnatal exposure in several areas of Poland and their im-pact on course and outcome of pregnancy and children's health.
This protocol concerns the children that are followed-up from birth to the age of 2 years to determine long term effects of pre- and postnatal environmental exposures.
Read the detailed description
The Polish Mother and Child Cohort is multicentre prospective study on different exposures.
Prospective cohort study design enables identification of exposures that may influence pregnancy outcome and chil-dren's health, verification of such exposures by biomarker measurements and notification of any changes in exposure levels.
The aim of the study is to evaluate the impact of exposure to different environmental factors during pregnancy and after birth on pregnancy outcome and children's health. Specific research hypotheses refer to the role of heavy metals, exposure to polycyclic aromatic hydrocar-bons (PAHs) and environmental tobacco smoke (ETS) in the aetiology of intrauterine growth retardation (IUGR), preterm delivery (PD) and the risk of respiratory diseases, allergy and poor mental and physical development. It is also intended to explain the role of oxidative stress and nutritional status of the pregnant women. The impact of occupational exposures and stressful situations on pregnancy outcome will be evaluated from question-naire data.
The results of the study will help to determine levels of child prenatal and postnatal exposure in several areas of Poland and their im-pact on course and outcome of pregnancy and children's health.
This protocol concerns the children that are followed-up from birth to the age of 2 years to deter-mine long term effects of pre- and postnatal environmental exposures.
Exposure of children to ETS. Postnatal children exposure to ETS at 12, and 24 months after birth is assessed. From the children urine sample and saliva samples from mothers who will declare smoking abstinence are collected. The saliva and urine cotinine level is analysed using high performance liquid chromatography coupled with tandem mass spectrometry/positive electrospray ionization (LC-ESI+MS/MS) and isotope dilution.
Exposure of children to PAH. The HPLC technique is used for the analysis of the level of 1-hydroksypyrene in urine as the biomarker of PAH exposure (12 and 24 months).
Exposure to lead, cadmium, mercury in children. Blood and hair are collected for about 100 children. Total and inorganic mercury is analyzed using cold vapour atomic fluorescence spectrophotometry. The lead and cadmium concentrations in blood is determined by graphite-furnance atomic-absorption spectrometry.
Exposure to indoor allergens, endotoxins and glucans. The analyzis is covered approx. 50 family homes of children. The settled dust is collected from floors in leaving rooms and in children beds (mattresses and blankets). To determine allergens concentrations in dust samples, the commercially available enzymelinked immunosorbent assey (ELISA) kits ispplied according to the protocol.To determine endotoxins and (1→3)-β-D-glucans concentrations the LAL test will be applied. The questionnaire study is performed among parents in order to obtain the data about demographic factors and home conditions.
Questionnaires conducted with mothers 12, and 24 months after delivery. Mothers of all children are interviewed. The questionnaires investigate the children's health and development, the nutrition of the small child and their contacts with other children. The smoking status of the parents and other potential sources of children's ETS exposure are identified. Information about proximity to heavy traffic is inquired. Additionally the information from the closets to his/her place of living air pollution monitoring station is collected. Exposure to other environmental factors including domestic animals, home dust, household cleaning agents and indoor used pesticides is evaluated by the questionnaire.
Determination of the prevalence of the upper and lower respiratory tract infections, middle ear diseases and allergy among the child. The incidence of the upper and lower respiratory tract infections, middle ear diseases and symptoms of allergy among the child is identified based on the detailed interview with the mothers in 12 and 24 month after child birth. This interviews is conducted by paediatricians. For each child upper and lower respiratory tract infections (tonsillitis, laryngitis, bronchitis and pneumonia), as well as middle ear diseases and allergy to food and inhalant allergens is identified based on the review of their medical charts. The duration of each infection and disease, medications taken and hospitalization is identified. The current health status of the chid and child' anthropometry (high, weight) is preformed by pediatrician.
Determination of the neurodevelopment of the children. BSID-III is used for assessment of child neurodevelopment. The tests is scheduled on 12 and/ 24 months of live and is conducted by psychologist or child development specialist. The test assesses five developmental areas of the child: cognitive, motor (fine and gross motor), language (receptive, expressive), social-emotional and adaptive behavior.
- Conditions
- Asthma, Atopic Dermatitis, Food Allergy, Wheezing
- Medical subject headings
- Asthma, Dermatitis, Atopic, Food Hypersensitivity, Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children (up to 24 months after birth) | Investigators include into the study children delivered from women observed starting from between 8-12 weeks of single pregnancy, not assisted with reproductive technology, and not expected to be finished as spontaneous abor-tion. All women with the serious chronic diseases specified in study protocol such as diabetes, hypertension, nephrop-athy, epilepsy and cancer are excluded from the study. The same refers to suspicion of serious child malformations known to exist at the inclusion into the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exposure of children to Environmental tobacco smoke(ETS)
Postnatal children exposure to ETS at 12, and 24 months after birth is assessed. From the children urine sample and saliva samples from mothers who will declare smoking abstinence are collected. The saliva and urine cotinine level is analysed using high performance liquid chromatography coupled with tandem mass spectrometry/positive electrospray ionization (LC-ESI+MS/MS) and isotope dilution.
Measured: Change from baseline of exposure of children to environmental tobacco smoke at 12 months
Secondary outcomes (6)
Exposure of children to polycyclic aromatic hydrocarbons (PAH)
The high performance liquid chromatography (HPLC) technique is used for the analysis of the level of 1-hydroksypyrene in urine as the biomarker of PAH exposure.
Measured: Change from baseline of exposure of children to polycyclic aromatic hydrocarbons at 12 months
Exposure to lead, cadmium, mercury in children.
Blood and hair are collected for about 100 children. Total and inorganic mercury is analyzed using cold vapour atomic fluorescence spectrophotometry. The lead and cadmium concentrations in blood is determined by graphite-furnance atomic-absorption spectrometry.
Measured: Change from baseline of exposure to lead, cadmium, mercury in children at 12 months.
Exposure to indoor allergens, endotoxins and glucans in children.
The analyzis is covered approx. 50 family homes of children. The settled dust is collected from floors in leaving rooms and in children beds (mattresses and blankets). To determine allergens concentrations in dust samples, the commercially available enzymelinked immunosorbent assey (ELISA) kits ispplied according to the protocol.To determine endotoxins and (1→3)-β-D-glucans concentrations the LAL test will be applied. The questionnaire study is performed among parents in order to obtain the data about demographic factors and home conditions.
Measured: Change from baseline of exposure to indoor allergens, endotoxins and glucans in children at 12 months.
Questionnaires conducted with mothers.
Mothers of all children are interviewed. The questionnaires investigate the children's health and development, the nutrition of the small child and their contacts with other children. The smoking status of the parents and other potential sources of children's ETS exposure are identified. Information about proximity to heavy traffic is inquired. Additionally the information from the closets to his/her place of living air pollution monitoring station is collected. Exposure to other environmental factors including domestic animals, home dust, household cleaning agents and indoor used pesticides is evaluated by the questionnaire.
Measured: Change from baseline of questionnaires scores at 12 months.
Determination of the prevalence of the upper and lower respiratory tract infections, middle ear diseases and allergy among the child.
The incidence of the upper and lower respiratory tract infections, middle ear diseases and symptoms of allergy among the child is identified based on the detailed interview with the mothers in 12 and 24 month after child birth. This interviews is conducted by paediatricians. For each child upper and lower respiratory tract infections (tonsillitis, laryngitis, bronchitis and pneumonia), as well as middle ear diseases and allergy to food and inhalant allergens is identified based on the review of their medical charts. The duration of each infection and disease, medications taken and hospitalization is identified. The current health status of the chid and child' anthropometry (high, weight) is preformed by pediatrician.
Measured: Change from baseline of the prevalence of infections and allergies at 12 months
Determination of the neurodevelopment of the children.
Bayley Scales of Infant Development (BSID-III) is used for assessment of child neurodevelopment. The tests is scheduled on 12 and/ 24 months of live and is conducted by psychologist or child development specialist. The test assesses five developmental areas of the child: cognitive, motor (fine and gross motor), language (receptive, expressive), social-emotional and adaptive behavior.
Measured: Change from baseline of the neurodevelopment of the children at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study startJan 2007
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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
- 479 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iwona Stelmach, Medical University of Lodz
- Investigators
- Iwona Stelmach, MD,PhD,Prof., Principal investigator, Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital, Lodz, PolandMonika Kopka, MD, Principal investigator, Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital, Lodz, PolandWojciech Hanke, MD,PhD,Prof., Principal investigator, Nofer Institute of Occupational Medicine, Department of Environmental EpidemiologyKinga Polanska, MD, PhD, Principal investigator, Nofer Institute of Occupational Medicine, Department of Environmental Epidemiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861548
- Sponsor's protocol ID
- PBZ-MEiN-/8/2//2006
- Other IDs
- PNRF-218-AI-1/07
- Acronym
- REPRO_PL
- Status last verified
- May 2013
- First submitted
- 17 May 2013
- Last updated
- 23 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Podlecka D, Jerzynska J, Sanad K, Polanska K, Bobrowska-Korzeniowska M, Stelmach I, Brzozowska A. Micronutrients and the Risk of Allergic Diseases in School Children. Int J Environ Res Public Health. 2022 Sep 26;19(19):12187. doi: 10.3390/ijerph191912187.
PubMed 36231487Stelmach I, Bobrowska-Korzeniowska M, Smejda K, Majak P, Jerzynska J, Stelmach W, Polanska K, Sobala W, Krysicka J, Hanke W. Risk factors for the development of atopic dermatitis and early wheeze. Allergy Asthma Proc. 2014 Sep-Oct;35(5):382-9. doi: 10.2500/aap.2014.35.3786.
PubMed 25295805Stelmach I, Grzelewski T, Bobrowska-Korzeniowska M, Kopka M, Majak P, Jerzynska J, Stelmach W, Polanska K, Sobala W, Gromadzinska J, Wasowicz W, Hanke W. The role of zinc, copper, plasma glutathione peroxidase enzyme, and vitamins in the development of allergic diseases in early childhood: The Polish mother and child cohort study. Allergy Asthma Proc. 2014 May-Jun;35(3):227-32. doi: 10.2500/aap.2014.35.3748.
PubMed 24801465
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polish Mother and Child Cohort Study (REPRO_PL).Follow up of the Children.
- ClinicalTrials.gov ID
- NCT01861548
- Acronym / sponsor ID
- REPRO_PL / PBZ-MEiN-/8/2//2006
- Conditions
- Asthma, Atopic Dermatitis, Food Allergy, Wheezing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 479 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 23 May 2013 (estimated)
- 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.
The Polish Mother and Child Cohort is multicentre prospective study on different exposures.
Prospective cohort study design enables identification of exposures that may influence pregnancy outcome and chil-dren's health, verification of such exposures by biomarker measurements and notification of any changes in exposure levels.
The aim of the study is to evaluate the impact of exposure to different environmental factors during pregnancy and after birth on pregnancy outcome and children's health. Specific research hypotheses refer to the role of heavy metals, exposure to polycyclic aromatic hydrocar-bons (PAHs) and environmental tobacco smoke (ETS) in the aetiology of intrauterine growth retardation (IUGR), preterm delivery (PD) and the risk of respiratory diseases, allergy and poor mental and physical development. It is also intended to explain the role of oxidative stress and nutritional status of the pregnant women. The impact of occupational exposures and stressful situations on pregnancy outcome will be evaluated from question-naire data.
The results of the study will help to determine levels of child prenatal and postnatal exposure in several areas of Poland and their im-pact on course and outcome of pregnancy and children's health.
This protocol concerns the children that are followed-up from birth to the age of 2 years to determine long term effects of pre- and postnatal environmental exposures.
Detailed description
The Polish Mother and Child Cohort is multicentre prospective study on different exposures.
Prospective cohort study design enables identification of exposures that may influence pregnancy outcome and chil-dren's health, verification of such exposures by biomarker measurements and notification of any changes in exposure levels.
The aim of the study is to evaluate the impact of exposure to different environmental factors during pregnancy and after birth on pregnancy outcome and children's health. Specific research hypotheses refer to the role of heavy metals, exposure to polycyclic aromatic hydrocar-bons (PAHs) and environmental tobacco smoke (ETS) in the aetiology of intrauterine growth retardation (IUGR), preterm delivery (PD) and the risk of respiratory diseases, allergy and poor mental and physical development. It is also intended to explain the role of oxidative stress and nutritional status of the pregnant women. The impact of occupational exposures and stressful situations on pregnancy outcome will be evaluated from question-naire data.
The results of the study will help to determine levels of child prenatal and postnatal exposure in several areas of Poland and their im-pact on course and outcome of pregnancy and children's health.
This protocol concerns the children that are followed-up from birth to the age of 2 years to deter-mine long term effects of pre- and postnatal environmental exposures.
Exposure of children to ETS. Postnatal children exposure to ETS at 12, and 24 months after birth is assessed. From the children urine sample and saliva samples from mothers who will declare smoking abstinence are collected. The saliva and urine cotinine level is analysed using high performance liquid chromatography coupled with tandem mass spectrometry/positive electrospray ionization (LC-ESI+MS/MS) and isotope dilution.
Exposure of children to PAH. The HPLC technique is used for the analysis of the level of 1-hydroksypyrene in urine as the biomarker of PAH exposure (12 and 24 months).
Exposure to lead, cadmium, mercury in children. Blood and hair are collected for about 100 children. Total and inorganic mercury is analyzed using cold vapour atomic fluorescence spectrophotometry. The lead and cadmium concentrations in blood is determined by graphite-furnance atomic-absorption spectrometry.
Exposure to indoor allergens, endotoxins and glucans. The analyzis is covered approx. 50 family homes of children. The settled dust is collected from floors in leaving rooms and in children beds (mattresses and blankets). To determine allergens concentrations in dust samples, the commercially available enzymelinked immunosorbent assey (ELISA) kits ispplied according to the protocol.To determine endotoxins and (1→3)-β-D-glucans concentrations the LAL test will be applied. The questionnaire study is performed among parents in order to obtain the data about demographic factors and home conditions.
Questionnaires conducted with mothers 12, and 24 months after delivery. Mothers of all children are interviewed. The questionnaires investigate the children's health and development, the nutrition of the small child and their contacts with other children. The smoking status of the parents and other potential sources of children's ETS exposure are identified. Information about proximity to heavy traffic is inquired. Additionally the information from the closets to his/her place of living air pollution monitoring station is collected. Exposure to other environmental factors including domestic animals, home dust, household cleaning agents and indoor used pesticides is evaluated by the questionnaire.
Determination of the prevalence of the upper and lower respiratory tract infections, middle ear diseases and allergy among the child. The incidence of the upper and lower respiratory tract infections, middle ear diseases and symptoms of allergy among the child is identified based on the detailed interview with the mothers in 12 and 24 month after child birth. This interviews is conducted by paediatricians. For each child upper and lower respiratory tract infections (tonsillitis, laryngitis, bronchitis and pneumonia), as well as middle ear diseases and allergy to food and inhalant allergens is identified based on the review of their medical charts. The duration of each infection and disease, medications taken and hospitalization is identified. The current health status of the chid and child' anthropometry (high, weight) is preformed by pediatrician.
Determination of the neurodevelopment of the children. BSID-III is used for assessment of child neurodevelopment. The tests is scheduled on 12 and/ 24 months of live and is conducted by psychologist or child development specialist. The test assesses five developmental areas of the child: cognitive, motor (fine and gross motor), language (receptive, expressive), social-emotional and adaptive behavior.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children (up to 24 months after birth) | – | –Investigators include into the study children delivered from women observed starting from between 8-12 weeks of single pregnancy, not assisted with reproductive technology, and not expected to be finished as spontaneous abor-tion. All women with the serious chronic diseases specified in study protocol such as diabetes, hypertension, nephrop-athy, epilepsy and cancer are excluded from the study. The same refers to suspicion of serious child malformations known to exist at the inclusion into the study. |
Who may qualify
- Ages
- 1 minute to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Investigators include into the study children delivered from women observed starting from between 8-12 weeks of single pregnancy, not assisted with reproductive technology, and not expected to be finished as spontaneous abor-tion. All women with the serious chronic diseases specified in study protocol such as diabetes, hypertension, nephrop-athy, epilepsy and cancer are excluded from the study. The same refers to suspicion of serious child malformations known to exist at the inclusion into the study.
Key inclusion criteria (1 listed)
- Investigators include into the study children delivered from women observed starting from between 8-12 weeks of single pregnancy, not assisted with reproductive technology, and not expected to be finished as spontaneous abor-tion. All women with the serious chronic diseases specified in study protocol such as diabetes, hypertension, nephrop-athy, epilepsy and cancer are excluded from the study. The same refers to suspicion of serious child malformations known to exist at the inclusion into the study.
Key exclusion criteria (2 listed)
- Serious child malformations known to exist at the inclusion into the study.
- Children delivered from all women with the serious chronic diseases specified in study protocol such as diabetes, hypertension, nephrop-athy, epilepsy and cancer are excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Exposure of children to Environmental tobacco smoke(ETS)
Time frame: Change from baseline of exposure of children to environmental tobacco smoke at 12 months
Postnatal children exposure to ETS at 12, and 24 months after birth is assessed. From the children urine sample and saliva samples from mothers who will declare smoking abstinence are collected. The saliva and urine cotinine level is analysed using high performance liquid chromatography coupled with tandem mass spectrometry/positive electrospray ionization (LC-ESI+MS/MS) and isotope dilution.
6 secondary outcomes
Exposure of children to polycyclic aromatic hydrocarbons (PAH)
Time frame: Change from baseline of exposure of children to polycyclic aromatic hydrocarbons at 12 months
Exposure to lead, cadmium, mercury in children.
Time frame: Change from baseline of exposure to lead, cadmium, mercury in children at 12 months.
Exposure to indoor allergens, endotoxins and glucans in children.
Time frame: Change from baseline of exposure to indoor allergens, endotoxins and glucans in children at 12 months.
Questionnaires conducted with mothers.
Time frame: Change from baseline of questionnaires scores at 12 months.
Determination of the prevalence of the upper and lower respiratory tract infections, middle ear diseases and allergy among the child.
Time frame: Change from baseline of the prevalence of infections and allergies at 12 months
Determination of the neurodevelopment of the children.
Time frame: Change from baseline of the neurodevelopment of the children at 12 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 23 May 2013.
- Derived from this study: PubMed 36231487Podlecka D, Jerzynska J, Sanad K, Polanska K, Bobrowska-Korzeniowska M, Stelmach I, Brzozowska A. Micronutrients and the Risk of Allergic Diseases in School Children. Int J Environ Res Public Health. 2022 Sep 26;19(19):12187. doi: 10.3390/ijerph191912187.
- Derived from this study: PubMed 25295805Stelmach I, Bobrowska-Korzeniowska M, Smejda K, Majak P, Jerzynska J, Stelmach W, Polanska K, Sobala W, Krysicka J, Hanke W. Risk factors for the development of atopic dermatitis and early wheeze. Allergy Asthma Proc. 2014 Sep-Oct;35(5):382-9. doi: 10.2500/aap.2014.35.3786.
- Derived from this study: PubMed 24801465Stelmach I, Grzelewski T, Bobrowska-Korzeniowska M, Kopka M, Majak P, Jerzynska J, Stelmach W, Polanska K, Sobala W, Gromadzinska J, Wasowicz W, Hanke W. The role of zinc, copper, plasma glutathione peroxidase enzyme, and vitamins in the development of allergic diseases in early childhood: The Polish mother and child cohort study. Allergy Asthma Proc. 2014 May-Jun;35(3):227-32. doi: 10.2500/aap.2014.35.3748.
- Study Internet siteLink provided by the sponsor.
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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.
Iwona Stelmach, MD,PhD,Prof. principal investigator
Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital, Lodz, Poland
Monika Kopka, MD principal investigator
Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital, Lodz, Poland
Wojciech Hanke, MD,PhD,Prof. principal investigator
Nofer Institute of Occupational Medicine, Department of Environmental Epidemiology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Atopic Dermatitis, run by Medical University of Lodz at 2 sites in Poland.
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 1 inclusion and 2 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 23 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. 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?
Exposure of children to Environmental tobacco smoke(ETS) (time frame: Change from baseline of exposure of children to environmental tobacco smoke at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01861548, which also lists 3 linked publications.
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 23 May 2013.