Iron and Pollen Allergy in Women

Phase

N/A

Condition

Allergy

Allergies & Asthma

Treatment

N/A

Clinical Study ID

NCT03816800

1370/2018

Ages 18-50
Female
Accepts Healthy Volunteers

Study 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

clinical reactivity 2) iron status and 3) changes in the microflora due to the treatment will be assessed.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Participants will be healthy premenopausal women over 18 years of age. Allergicparticipants should have been diagnosed with allergic rhinitis against birch and/orgrass pollen.

Exclusion

Exclusion Criteria:

Subjects with co-morbidities such as diabetes mellitus, disorders of the liverincluding hemochromatosis or kidney, autoimmune and metabolic diseases or malignanciesor who use medications (e.g. antibiotics, PPIs) that influence the iron, inflammatoryor microbial status will be excluded. Further exclusion criteria are pregnancy,lactation, zinc, and iron supplementation and smoking. Subjects with a history ofmajor bleeding (including trauma, surgery, other major blood loss) within the last 2years and blood transfusion within the last 2 years, or with a history of significantbreakthrough bleeding will be excluded. Volunteers will be asked to cease blooddonation at least three months before recruitment. Allergics with a history of anallergen-induced anaphylactic shock or with severe, uncontrolled asthma who in thelast two years have received allergen immunotherapy or an anti-IgE therapy will beexcluded.

Study Design

January 28, 2019

October 29, 2020

Study 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.

Connect with a study center

Medical University of Vienna
Vienna, 1090
Austria
Site Not Available

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