Back to resultsIron and Pollen Allergy in Women
Primary Purpose
Allergy Pollen, Healthy
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
ImmunoBon
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Allergy Pollen focused on measuring Allergy, iron-deficiency, birch, grass
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Medical University of Vienna
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo-Allergic
Active-Allergic
Arm Description
Over the course of 6 months allergic participants receive twice daily a placebo tablets.
Over the course of 6 months allergic participants receive twice daily a dietary supplement containing whey protein-bound, chelated iron.
Outcomes
Primary Outcome Measures
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)
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)
Secondary Outcome Measures
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
Iron status
Hemoglobin, Ferritin, hepcidin, hemopexin,ceruloplasmin, iron and soluble transferrin receptor concentrations, transferrin saturation in %
Iron status
Hemoglobin, Ferritin, hepcidin, hemopexin,ceruloplasmin, iron and soluble transferrin receptor concentrations, transferrin saturation in %
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
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
Full Information
NCT ID
NCT03816800
First Posted
January 21, 2019
Last Updated
August 30, 2021
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT03816800
Brief Title
Iron and Pollen Allergy in Women
Official Title
Investigating the Association of Iron and Pollen Allergy in Female Subjects Studie Zur Wirkung Von Eisen Auf Pollenallergikerinnen
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 28, 2019 (Actual)
Primary Completion Date
October 28, 2020 (Actual)
Study Completion Date
October 29, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergy Pollen, Healthy
Keywords
Allergy, iron-deficiency, birch, grass
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo-Allergic
Arm Type
Placebo Comparator
Arm Description
Over the course of 6 months allergic participants receive twice daily a placebo tablets.
Arm Title
Active-Allergic
Arm Type
Active Comparator
Arm Description
Over the course of 6 months allergic participants receive twice daily a dietary supplement containing whey protein-bound, chelated iron.
Intervention Type
Dietary Supplement
Intervention Name(s)
ImmunoBon
Intervention Description
The dietary agent contains vitamin A, Zn, chelated iron and whey proteins.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
the dietary agent does not contain vitamin A, Zn, chelated iron and whey proteins
Primary Outcome Measure Information:
Title
Symptom severity - Total nasal symptom score
Description
Symptoms (with max 2 points for secretions, irritations and distant symptoms): score of 6 means all symptoms present (secretion, irritations and distant symptoms)
Time Frame
Baseline
Title
Symptom severity - Total nasal symptom score
Description
Symptoms (with max 2 points for secretions, irritations and distant symptoms): score of 6 means all symptoms present (secretion, irritations and distant symptoms)
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Mean daily combined symptom medication score during the peak of the pollen season
Description
The score will be recorded daily for 45-180 days during the pollen season
Time Frame
up to 6 months
Title
Iron status
Description
Hemoglobin, Ferritin, hepcidin, hemopexin,ceruloplasmin, iron and soluble transferrin receptor concentrations, transferrin saturation in %
Time Frame
Baseline
Title
Iron status
Description
Hemoglobin, Ferritin, hepcidin, hemopexin,ceruloplasmin, iron and soluble transferrin receptor concentrations, transferrin saturation in %
Time Frame
8 months
Title
Exploratory - Microbiome
Description
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
Time Frame
baseline
Title
Exploratory - Microbiome
Description
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
Time Frame
8 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
premenopausal women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franziska Roth-Walter, PhD
Organizational Affiliation
The interuniversity Messerli Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Citations:
PubMed Identifier
34037999
Citation
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.
Results Reference
derived
Learn more about this trial
Iron and Pollen Allergy in Women
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