NCT03816800

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 25, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

January 28, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2020

Completed
Last Updated

September 5, 2021

Status Verified

August 1, 2021

Enrollment Period

1.8 years

First QC Date

January 21, 2019

Last Update Submit

August 30, 2021

Conditions

Allergy PollenHealthy

Keywords

Allergyiron-deficiencybirchgrass

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (5)

  • Mean daily combined symptom medication score during the peak of the pollen season

    up to 6 months

  • Iron status

    Baseline

  • Iron status

    8 months

  • Exploratory - Microbiome

    baseline

  • Exploratory - Microbiome

    8 months

Study Arms (2)

Placebo-Allergic

PLACEBO COMPARATOR

Over the course of 6 months allergic participants receive twice daily a placebo tablets.

Dietary Supplement: Placebo

Active-Allergic

ACTIVE COMPARATOR

Over the course of 6 months allergic participants receive twice daily a dietary supplement containing whey protein-bound, chelated iron.

Dietary Supplement: ImmunoBon

Interventions

ImmunoBonDIETARY_SUPPLEMENT

The dietary agent contains vitamin A, Zn, chelated iron and whey proteins.

Active-Allergic
PlaceboDIETARY_SUPPLEMENT

the dietary agent does not contain vitamin A, Zn, chelated iron and whey proteins

Placebo-Allergic

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspremenopausal women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

  • 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.

    PMID: 34037999DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic, SeasonalHypersensitivityAnemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateImmune System DiseasesAnemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Franziska Roth-Walter, PhD

    The interuniversity Messerli Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 21, 2019

First Posted

January 25, 2019

Study Start

January 28, 2019

Primary Completion

October 28, 2020

Study Completion

October 29, 2020

Last Updated

September 5, 2021

Record last verified: 2021-08

Locations

AU(1)