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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo-Allergic | Placebo Comparator | Over the course of 6 months allergic participants receive twice daily a placebo tablets. |
|
| Active-Allergic | Active Comparator | Over the course of 6 months allergic participants receive twice daily a dietary supplement containing whey protein-bound, chelated iron. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ImmunoBon | Dietary Supplement | The dietary agent contains vitamin A, Zn, chelated iron and whey proteins. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 6 months |
| Iron status | Hemoglobin, Ferritin, hepcidin, hemopexin,ceruloplasmin, iron and soluble transferrin receptor concentrations, transferrin saturation in % |
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Inclusion Criteria:
Exclusion Criteria:
premenopausal women
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| Name | Affiliation | Role |
|---|---|---|
| Franziska Roth-Walter, PhD | The interuniversity Messerli Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Vienna | 1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34037999 | Derived | 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. |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| D006967 | Hypersensitivity |
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| Placebo | Dietary Supplement | the dietary agent does not contain vitamin A, Zn, chelated iron and whey proteins |
|
| Baseline |
| Iron status | Hemoglobin, Ferritin, hepcidin, hemopexin,ceruloplasmin, iron and soluble transferrin receptor concentrations, transferrin saturation in % | 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 | 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 | 8 months |
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000090463 | Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |