Allergy PollenNCT03816800
Iron and Pollen Allergy in Women
A study testing ImmunoBon in people with Allergy Pollen and Healthy, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Iron deficiency and anemia are clearly associated with the onset of allergy and allergic diseases, whereas an improved iron status seems to prevent the onset of allergy in humans. Iron-deficiency can be absolute or functional. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Allergy Pollen, Healthy
- What is being tested?
- ImmunoBon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteAustria
- Study dates
- 28 Jan 2019to 29 Oct 2020
- Phase
- Interventional
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants will be healthy premenopausal women over 18 years of age. Allergic participants should have been diagnosed with allergic rhinitis against birch and/or grass pollen.
Who cannot join
- Subjects with co-morbidities such as diabetes mellitus, disorders of the liver including hemochromatosis or kidney, autoimmune and metabolic diseases or malignancies or who use medications (e.g. antibiotics, PPIs) that influence the iron, inflammatory or microbial status will be excluded. Further exclusion criteria are pregnancy, lactation, zinc, and iron supplementation and smoking. Subjects with a history of major bleeding (including trauma, surgery, other major blood loss) within the last 2 years and blood transfusion within the last 2 years, or with a history of significant breakthrough bleeding will be excluded. Volunteers will be asked to cease blood donation at least three months before recruitment. Allergics with a history of an allergen-induced anaphylactic shock or with severe, uncontrolled asthma who in the last two years have received allergen immunotherapy or an anti-IgE therapy will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Association of Iron and Pollen Allergy in Female Subjects Studie Zur Wirkung Von Eisen Auf Pollenallergikerinnen
Iron deficiency and anemia are clearly associated with the onset of allergy and allergic diseases, whereas an improved iron status seems to prevent the onset of allergy in humans. Iron-deficiency can be absolute or functional. Functional iron-deficiency occurs during immune activation and may be reflective for the hyperactive state of atopic subjects.
The investigators plan a prophylactic dietary intervention study in atopic/allergic and non-allergic individuals that transport chelated iron to immune cells. Over the course of six months, oral supplementation of placebo or whey protein-bound chelated iron will be given and 1) clinical reactivity 2) iron status and 3) changes in the microflora due to the treatment will be assessed.
Read the detailed description
There is no state-of-the-art prophylactic treatment for atopy. Once allergy develops, allergens should be avoided, and specific allergen immunotherapy applied. The initial cause of the onset of allergy, namely the immune hyperactive state of the atopic subjects, is not addressed at all. The investigators hypothesize that atopy is defined by a mild functional iron deficiency and that improving the iron status of immune cells will decrease the reactivity of these cells.
In this prophylactic dietary intervention study oral supplementation of placebo or chelated and whey protein-bound iron will be given over the course of six months to allergic and non-allergic women. Changes in 1) the clinical reactivity 2) the iron status and 3) the microflora will be assessed. The study will be the first systematic approach in humans to assess the contribution of iron deficiency to allergy and will be pivotal in supporting the implementation of prophylactic and therapeutic recommendations.
- Conditions
- Allergy Pollen, Healthy
- Being tested
- ImmunoBon, Placebo
- Keywords
- Allergy, iron-deficiency, birch, grass
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Hypersensitivity, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunoBonDietary supplement
The dietary agent contains vitamin A, Zn, chelated iron and whey proteins.
PlaceboDietary supplement
the dietary agent does not contain vitamin A, Zn, chelated iron and whey proteins
| Study group | Role | What they receive |
|---|---|---|
| Placebo-Allergic | Placebo comparator | Over the course of 6 months allergic participants receive twice daily a placebo tablets. Receives: Dietary Supplement: Placebo |
| Active-Allergic | Active comparator | Over the course of 6 months allergic participants receive twice daily a dietary supplement containing whey protein-bound, chelated iron. Receives: Dietary Supplement: ImmunoBon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom severity - Total nasal symptom score
Symptoms (with max 2 points for secretions, irritations and distant symptoms): score of 6 means all symptoms present (secretion, irritations and distant symptoms)
Measured: Baseline
Symptom severity - Total nasal symptom score
Symptoms (with max 2 points for secretions, irritations and distant symptoms): score of 6 means all symptoms present (secretion, irritations and distant symptoms)
Measured: 8 months
Secondary outcomes (5)
Mean daily combined symptom medication score during the peak of the pollen season
The score will be recorded daily for 45-180 days during the pollen season
Measured: up to 6 months
Iron status
Hemoglobin, Ferritin, hepcidin, hemopexin,ceruloplasmin, iron and soluble transferrin receptor concentrations, transferrin saturation in %
Measured: Baseline
Iron status
Hemoglobin, Ferritin, hepcidin, hemopexin,ceruloplasmin, iron and soluble transferrin receptor concentrations, transferrin saturation in %
Measured: 8 months
Exploratory - Microbiome
microbial composition will be assessed by 16S rRNA sequencing in order to determine bacterial communities present in samples, their relative abundance and overall diversity. Samples: gastrointestinal and nasal samples
Measured: baseline
Exploratory - Microbiome
microbial composition will be assessed by 16S rRNA sequencing in order to determine bacterial communities present in samples, their relative abundance and overall diversity. Samples: gastrointestinal and nasal samples
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start28 Jan 2019
- Primary completion28 Oct 2020
- Study completion29 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergy PollenStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franziska Roth-Walter, Medical University of Vienna
- Investigators
- Franziska Roth-Walter, PhD, Principal investigator, The interuniversity Messerli Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03816800
- Sponsor's protocol ID
- 1370/2018
- Status last verified
- Aug 2021
- First submitted
- 21 Jan 2019
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Petje LM, Jensen SA, Szikora S, Sulzbacher M, Bartosik T, Pjevac P, Hausmann B, Hufnagl K, Untersmayr E, Fischer L, Vyskocil E, Eckl-Dorna J, Jensen-Jarolim E, Hofstetter G, Afify SM, Krenn CG, Roth GA, Rivelles E, Hann S, Roth-Walter F. Functional iron-deficiency in women with allergic rhinitis is associated with symptoms after nasal provocation and lack of iron-sequestering microbes. Allergy. 2021 Sep;76(9):2882-2886. doi: 10.1111/all.14960. Epub 2021 Jun 17. No abstract available.
PubMed 34037999
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Association of Iron and Pollen Allergy in Female Subjects Studie Zur Wirkung Von Eisen Auf Pollenallergikerinnen
- ClinicalTrials.gov ID
- NCT03816800
- Acronym / sponsor ID
- 1370/2018
- Conditions
- Allergy Pollen, Healthy
- Keywords
- Allergy, iron-deficiency, birch, grass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 28 Jan 2019 (actual)
- Primary completion
- 28 Oct 2020 (actual)
- Study completion
- 29 Oct 2020 (actual)
- First posted
- 25 Jan 2019 (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.
Iron deficiency and anemia are clearly associated with the onset of allergy and allergic diseases, whereas an improved iron status seems to prevent the onset of allergy in humans. Iron-deficiency can be absolute or functional. Functional iron-deficiency occurs during immune activation and may be reflective for the hyperactive state of atopic subjects.
The investigators plan a prophylactic dietary intervention study in atopic/allergic and non-allergic individuals that transport chelated iron to immune cells. Over the course of six months, oral supplementation of placebo or whey protein-bound chelated iron will be given and 1) clinical reactivity 2) iron status and 3) changes in the microflora due to the treatment will be assessed.
Detailed description
There is no state-of-the-art prophylactic treatment for atopy. Once allergy develops, allergens should be avoided, and specific allergen immunotherapy applied. The initial cause of the onset of allergy, namely the immune hyperactive state of the atopic subjects, is not addressed at all. The investigators hypothesize that atopy is defined by a mild functional iron deficiency and that improving the iron status of immune cells will decrease the reactivity of these cells.
In this prophylactic dietary intervention study oral supplementation of placebo or chelated and whey protein-bound iron will be given over the course of six months to allergic and non-allergic women. Changes in 1) the clinical reactivity 2) the iron status and 3) the microflora will be assessed. The study will be the first systematic approach in humans to assess the contribution of iron deficiency to allergy and will be pivotal in supporting the implementation of prophylactic and therapeutic recommendations.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo-Allergic | Placebo comparator | Dietary Supplement: PlaceboOver the course of 6 months allergic participants receive twice daily a placebo tablets. |
| Active-Allergic | Active comparator | Dietary Supplement: ImmunoBonOver the course of 6 months allergic participants receive twice daily a dietary supplement containing whey protein-bound, chelated iron. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants will be healthy premenopausal women over 18 years of age. Allergic participants should have been diagnosed with allergic rhinitis against birch and/or grass pollen.
Key exclusion criteria (1 listed)
- Subjects with co-morbidities such as diabetes mellitus, disorders of the liver including hemochromatosis or kidney, autoimmune and metabolic diseases or malignancies or who use medications (e.g. antibiotics, PPIs) that influence the iron, inflammatory or microbial status will be excluded. Further exclusion criteria are pregnancy, lactation, zinc, and iron supplementation and smoking. Subjects with a history of major bleeding (including trauma, surgery, other major blood loss) within the last 2 years and blood transfusion within the last 2 years, or with a history of significant breakthrough bleeding will be excluded. Volunteers will be asked to cease blood donation at least three months before recruitment. Allergics with a history of an allergen-induced anaphylactic shock or with severe, uncontrolled asthma who in the last two years have received allergen immunotherapy or an anti-IgE therapy will be excluded.
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 |
|---|---|---|
| ImmunoBonThe dietary agent contains vitamin A, Zn, chelated iron and whey proteins. | Dietary supplement | Active-Allergic |
| Placebothe dietary agent does not contain vitamin A, Zn, chelated iron and whey proteins | Dietary supplement | Placebo-Allergic |
Primary outcome
Symptom severity - Total nasal symptom score
Time frame: Baseline
Symptoms (with max 2 points for secretions, irritations and distant symptoms): score of 6 means all symptoms present (secretion, irritations and distant symptoms)
Symptom severity - Total nasal symptom score
Time frame: 8 months
Symptoms (with max 2 points for secretions, irritations and distant symptoms): score of 6 means all symptoms present (secretion, irritations and distant symptoms)
5 secondary outcomes
Mean daily combined symptom medication score during the peak of the pollen season
Time frame: up to 6 months
Iron status
Time frame: Baseline
Iron status
Time frame: 8 months
Exploratory - Microbiome
Time frame: baseline
Exploratory - Microbiome
Time frame: 8 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 5 Sep 2021.
- Derived from this study: PubMed 34037999Petje LM, Jensen SA, Szikora S, Sulzbacher M, Bartosik T, Pjevac P, Hausmann B, Hufnagl K, Untersmayr E, Fischer L, Vyskocil E, Eckl-Dorna J, Jensen-Jarolim E, Hofstetter G, Afify SM, Krenn CG, Roth GA, Rivelles E, Hann S, Roth-Walter F. Functional iron-deficiency in women with allergic rhinitis is associated with symptoms after nasal provocation and lack of iron-sequestering microbes. Allergy. 2021 Sep;76(9):2882-2886. doi: 10.1111/all.14960. Epub 2021 Jun 17. No abstract available.
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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.
Franziska Roth-Walter, PhD principal investigator
The interuniversity Messerli Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ImmunoBon in people with Allergy Pollen and Healthy, run by Medical University of Vienna at 1 site in Austria.
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 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 5 Sep 2021. 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 Austria. 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. Some participants in this study may receive a placebo. 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?
Symptom severity - Total nasal symptom score (time frame: Baseline). The study lists 2 primary outcomes in all. 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 NCT03816800, which also lists 1 linked publication.
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 5 Sep 2021.