Skip to content

Oslo Footballplayers Iron Supplementation and Training (FIT) Study

Iron Intake, Iron Status, Intestinal Health and Endurance Performance - Effects of Iron Supplementation in Young Female Football Players - a Pilot Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04526678
Acronym
Oslo-FIT
Enrollment
23
Registered
2020-08-26
Start date
2020-08-19
Completion date
2020-12-03
Last updated
2026-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Athletes, Endurance Performance, Hemoglobin, Intestinal Health, Iron, Microbiota

Keywords

oxidative stress, football

Brief summary

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

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.

Interventions

DIETARY_SUPPLEMENTIron 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.

Sponsors

Norwegian University of Life Sciences
Lead SponsorOTHER
Norwegian School of Sport Sciences
CollaboratorOTHER
University of Oslo
CollaboratorOTHER
Norwegian Olympic Sports Centre
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)

Masking description

The assessor of outcomes are blinded to group allocation.

Intervention model description

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

Eligibility

Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Diet composition3 monthsDiet composition will be assessed using digital 7 day dietary records.
Iron intake3 monthsIron intake will be calculated based on average daily intake of iron according to the digital 7 day dietary recordings.
Serum Iron3 monthsIron status will be assessed by analyzing serum iron (µmol/L)
Serum transferrin3 monthsIron status will be assessed by analyzing serum transferrin (µmol/L)
Serum ferritin3 monthsIron status will be assessed by analyzing serum ferritin (µg/L)
Hemoglobin levels3 monthshemoglobin (Hb) (g/dl) will be analyzed in whole blood (EDTA) using an automated hematology analyzer.
LPS binding protein3 months-Intestinal health will be measured using biomarkers of intestinal leakage in serum and feces such as sLPS binding protein (LBP) (ug/ml)
Neutrophil gelatinase-associated lipocalin3 months-Intestinal health will be measured using biomarkers of intestinal leakage in serum and feces such as fecal neutrophil gelatinase-associated lipocalin (NGAL) (ng/g feces)
Serum cytokines3 months-Intestinal health will be measured using serum biomarkers of systemic inflammation (e.g. serum cytokines such as IL-1, IL-6, and TNF-α pg/ml).
Sports performance3 monthsSports performance specific for football will be be measured using the Yo-Yo Intermittent Recovery Test (YYIR1).
Differential counts3 monthsDifferential counts (% of WBC) will be analyzed in whole blood (EDTA) using an automated hematology analyzer.
Ferric reducing ability of plasma3 months-Oxidative stress will be assessed measuring the ferric reducing ability of plasma (FRAP)
Diacron reactive oxygen metabolites3 months-Oxidative stress will be assessed measuring biomarkers of total oksidativ stress e.g. diacron reactive oxygen metabolites (dROM).
Microbiota composition3 months-Microbiota composition will be analyzed mainly using 16S rRNA gene sequencing. The main effect of the intervention on the microbiota will be tested based on crude alpha and beta diversity indices but we will also apply advanced multivariate methods.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 12, 2026