Clinical Trials Directory

Trials / Completed

CompletedNCT03816800

Iron and Pollen Allergy in Women

Investigating the Association of Iron and Pollen Allergy in Female Subjects Studie Zur Wirkung Von Eisen Auf Pollenallergikerinnen

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
58 (actual)
Sponsor
Medical University of Vienna · Academic / Other
Sex
Female
Age
18 Years – 50 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTImmunoBonThe dietary agent contains vitamin A, Zn, chelated iron and whey proteins.
DIETARY_SUPPLEMENTPlacebothe dietary agent does not contain vitamin A, Zn, chelated iron and whey proteins

Timeline

Start date
2019-01-28
Primary completion
2020-10-28
Completion
2020-10-29
First posted
2019-01-25
Last updated
2021-09-05

Locations

1 site across 1 country: Austria

Source: ClinicalTrials.gov record NCT03816800. Inclusion in this directory is not an endorsement.