Allergy Pollen, Healthy
Conditions
Keywords
Allergy, iron-deficiency, birch, grass
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.
Interventions
DIETARY_SUPPLEMENTImmunoBon
The dietary agent contains vitamin A, Zn, chelated iron and whey proteins.
DIETARY_SUPPLEMENTPlacebo
the dietary agent does not contain vitamin A, Zn, chelated iron and whey proteins
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom severity - Total nasal symptom score | Baseline | Symptoms (with max 2 points for secretions, irritations and distant symptoms): score of 6 means all symptoms present (secretion, irritations and distant symptoms) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean daily combined symptom medication score during the peak of the pollen season | up to 6 months | The score will be recorded daily for 45-180 days during the pollen season |
| Iron status | Baseline | Hemoglobin, Ferritin, hepcidin, hemopexin,ceruloplasmin, iron and soluble transferrin receptor concentrations, transferrin saturation in % |
| Exploratory - Microbiome | baseline | 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 |
Countries
Austria
Outcome results
None listed