Oslo Footballplayers Iron Supplementation and Training (FIT) Study

NCT ID: NCT04526678

Last Updated: 2025-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-11

Study Completion Date

2030-12-31

Brief Summary

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The aim of the study is to characterize the diet and iron status of young female elite football players and examine the relationship between iron intake, iron status, hemoglobin levels, intestinal health and sports performance. In addition, the effects of low-dose iron supplements on iron stores will be investigated and whether such supplementation affects intestinal health, microbiota composition and biomarkers for oxidative stress.

Detailed Description

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Iron deficiency can lead to fatigue and anemia. Because iron is necessary for the formation of new blood cells (hematopoiesis), it is an extensive practice internationally among athletes to take iron supplements in the belief that this will improve endurance performance and oxygen transport capacity by increasing red blood cell production. Although iron intake in menstruating women has shown to reduce the prevalence of anemia and iron deficiency as well as increasing hemoglobin values and iron stores. However iron supplementation increases the risk of iron excess and can result in undesirable effects such as constipation and abdominal pain as well as negative impact on intestinal epithelial permeability and increase in oxidative stress. Because iron is important for the replication and survival of almost all bacteria, with few exceptions, the intake of iron also affect the composition of the intestinal bacteria. Not surprisingly, both high and low iron levels affect the composition of the microbiota in the gut.

It is not known if young menstruating Norwegian female athletes cover their need for iron via the diet or whether extra intake in the form of a low-dose supplement could be beneficial in terms of hemoglobin levels and sports performance. Because iron preparations are not prescription and are sold in pharmacies, health food stores and larger grocery stores, this can lead to uncritical intake of iron. Since the use of iron preparations has been documented to be widespread in foreign sports environments, it is important to both characterize the iron status of Norwegian athletes and at the same time examine the beneficial value of iron supplements on sports performance as well as monitoring effects on microbiota composition and intestinal health.

The aim of the study is therefore to characterize the diet and iron status of young female elite football players and examine the relationship between iron intake, iron status, hemoglobin levels, intestinal health and sports performance. In addition, the effects of low-dose iron supplements will be investigated in relation to iron stores, hemoglobin levels and sports performance and whether such supplementation affects intestinal health, microbiota composition and biomarkers for oxidative stress.

Conditions

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Athletes Iron Endurance Performance Hemoglobin Intestinal Health Microbiota

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The intervention group will ingest 27 mg iron supplement per day for three months while the control group will not ingest iron supplements.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors
The assessor of outcomes are blinded to group allocation.

Study Groups

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Iron supplements

The intervention group will ingest 27 mg iron supplement per day for three months while the control group will not ingest iron supplements.

Group Type EXPERIMENTAL

Iron supplement (27mg)

Intervention Type DIETARY_SUPPLEMENT

The participants will be randomized to an intervention group or a control group. The intervention group will ingest 27mg iron daily for three months.

Control group

The control group will not ingest iron supplements.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Iron supplement (27mg)

The participants will be randomized to an intervention group or a control group. The intervention group will ingest 27mg iron daily for three months.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

\- Female elite football players from two selected football clubs

Exclusion Criteria

* Pregnancy
* Medical conditions that are worsened by taking iron supplements
* Already taking iron supplements
Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Norwegian School of Sport Sciences

OTHER

Sponsor Role collaborator

University of Oslo

OTHER

Sponsor Role collaborator

Norwegian Olympic Sports Centre

UNKNOWN

Sponsor Role collaborator

Norwegian University of Life Sciences

OTHER

Sponsor Role lead

Responsible Party

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Siv K Bohn

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Norwegian University of Life Sciences

Ås, , Norway

Site Status

Countries

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Norway

Other Identifiers

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969159570_KBM_SKB2020

Identifier Type: -

Identifier Source: org_study_id

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