Oslo Footballplayers Iron Supplementation and Training (FIT) Study

NCT04526678 | Active Not Recruiting

• 1 other identifier: 969159570_KBM_SKB2020
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

oxidative stress; football

Outcome Measures

Primary Outcomes (14)

• Diet composition

  Diet composition will be assessed using digital 7 day dietary records.

  3 months

• Iron intake

  Iron intake will be calculated based on average daily intake of iron according to the digital 7 day dietary recordings.

  3 months

• Serum Iron

  Iron status will be assessed by analyzing serum iron (µmol/L)

  3 months

• Serum transferrin

  Iron status will be assessed by analyzing serum transferrin (µmol/L)

  3 months

• Serum ferritin

  Iron status will be assessed by analyzing serum ferritin (µg/L)

  3 months

• Hemoglobin levels

  hemoglobin (Hb) (g/dl) will be analyzed in whole blood (EDTA) using an automated hematology analyzer.

  3 months

• LPS binding protein

  -Intestinal health will be measured using biomarkers of intestinal leakage in serum and feces such as sLPS binding protein (LBP) (ug/ml)

  3 months

• Neutrophil gelatinase-associated lipocalin

  -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)

  3 months

• Serum cytokines

  -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).

  3 months

• Sports performance

  Sports performance specific for football will be be measured using the Yo-Yo Intermittent Recovery Test (YYIR1).

  3 months

• Differential counts

  Differential counts (% of WBC) will be analyzed in whole blood (EDTA) using an automated hematology analyzer.

  3 months

• Ferric reducing ability of plasma

  -Oxidative stress will be assessed measuring the ferric reducing ability of plasma (FRAP)

  3 months

• Diacron reactive oxygen metabolites

  -Oxidative stress will be assessed measuring biomarkers of total oksidativ stress e.g. diacron reactive oxygen metabolites (dROM).

  3 months

• Microbiota composition

  -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.

  3 months

Study Arms (2)

Iron supplements

EXPERIMENTAL

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

Dietary Supplement: Iron supplement (27mg)

Control group

NO INTERVENTION

The control group will not ingest iron supplements.

Interventions

Iron supplement (27mg) 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.

Iron supplements

Eligibility Criteria

• Age: 16 Years+
• Gender Eligibility Details: Invited female elite football players from two selected football clubs.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Female elite football players from two selected football clubs

You may not qualify if:

• Pregnancy
• Medical conditions that are worsened by taking iron supplements
• Already taking iron supplements

Sponsors & Collaborators

• Norwegian University of Life Sciences: lead
• Norwegian School of Sport Sciences: collaborator
• University of Oslo: collaborator
• Norwegian Olympic Sports Centre: collaborator

Study Sites (1)

Norwegian University of Life Sciences

Ås, 1433, Norway

Location

MeSH Terms

Interventions

Iron-Dextran Complex

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor of outcomes are blinded to group allocation.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 26, 2020
• Study Start: August 11, 2020
• Primary Completion: December 3, 2020
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 23, 2025

Record last verified: 2025-05

Locations

NO (1)