- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07720960
Effects of Intermittent Hypoxia Training With Iron Supplementation on Red Blood Cells and Iron Levels in Trained Athletes (IHIT-IRON)
SHORT-TERM INTERMITTENT HYPOXIA TRAINING INDUCES POSITIVE ERYTHROPOIETIC ADAPTATIONS BUT DECREASING DRASTICALLY IRON RESERVES
This study investigates how training under conditions of reduced oxygen (intermittent hypoxia) affects the body's ability to produce red blood cells and manage iron levels, compared to training under normal oxygen conditions. Red blood cells are essential for transporting oxygen throughout the body, and their production depends on having enough available iron.
Thirty-two physically trained participants completed a 3-week training program, either in low-oxygen conditions or in normal oxygen conditions. All participants followed the same diet and received daily supplements of iron and vitamins to ensure adequate nutritional support.
The main hypothesis of this study is that training in low-oxygen conditions stimulates the production of red blood cells more strongly than training in normal oxygen conditions, and that this increased production requires the body to use stored iron, potentially lowering iron reserves.
Results showed that participants training in low-oxygen conditions experienced a greater increase in red blood cells and related markers compared to those training in normal conditions. At the same time, their stored iron levels decreased, suggesting that the body was using its iron reserves to support the increased production of red blood cells. In contrast, participants training in normal oxygen conditions showed smaller changes and maintained or slightly increased their iron stores.
These findings suggest that low-oxygen training can enhance the body's capacity to produce red blood cells but may also reduce iron reserves. This highlights the importance of monitoring iron levels during such training programs, especially in athletes or individuals with conditions related to low oxygen availability, such as anemia.
Overall, this study aims to improve understanding of how oxygen availability influences blood health and may help guide future strategies that combine hypoxia training and iron supplementation to support performance and treat certain medical conditions.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Alicante
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Elche, Alicante, Spanien, 03202
- University Miguel Hernández of Elche
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Male sex
- Adult age (≥18 years)
- Federated mountain sports practitioner (alpinist, trail runner, ski mountaineer, or endurance runner)
- Normal hemoglobin levels at screening (≥13 g/dL)
- Residence at elevations below 700 m
- Provision of written informed consent prior to enrollment
- Agreement to comply with the principles of the Declaration of Helsinki (WMA, 2024 revision)
Exclusion Criteria:
- Stay at altitudes above 2,000 m within the previous 2 months prior to enrollment
- Any form of anemia at screening (hemoglobin <12-13 g/dL)
- Sports-related pseudoanemia
- Presence of cardiovascular or respiratory pathologies, as determined by the medically supervised VO₂max exercise test
- Female sex
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Placebo komparator: Control group (CG)
Trained at sea-level conditions
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3-week normoxic training program (14 sessions, 90 min/session) with identical exercise structure to the hypoxia group (strength-resistance circuit + cycling intervals), performed at sea-level oxygen conditions inside the same tent to ensure blinding.
Frequency: 4-5 sessions/week.
All participants received daily oral supplementation: iron 60 mg (ferrous sulfate + ferrous fumarate) + vitamin C 200 mg + folic acid 200 µg + vitamin B12 6 µg.
Diet provided ~55 kcal/kg/day (carbohydrates 7-8 g/kg, protein 1.6-2 g/kg, fat 1-1.5 g/kg).
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Eksperimentel: Hypoxia group (HG)
Trained at simulated altitudes between 4,450 and 5,850 m
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3-week normobaric intermittent hypoxia training program (14 sessions, 90 min/session: 60 min active + 30 min passive hypoxia) at simulated altitudes of 4,450-5,850 m (SaO₂ ~80%).
Training combined strength-resistance circuit (30 min) and high-intensity cycling intervals (30 min).
Frequency: 4-5 sessions/week.
All participants received daily oral supplementation: iron 60 mg (ferrous sulfate + ferrous fumarate) + vitamin C 200 mg + folic acid 200 µg + vitamin B12 6 µg.
Diet provided ~55 kcal/kg/day (carbohydrates 7-8 g/kg, protein 1.6-2 g/kg, fat 1-1.5 g/kg).
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Hemoglobin concentration
Tidsramme: Baseline and 3 weeks (end of intervention)
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Venous blood hemoglobin concentration (g/dL) measured at baseline and 3 days after completion of the 3-week intervention.
Blood samples collected in the morning (08:00-10:00 h) after overnight fast (≥8 h) and 10 min of seated rest, analyzed by automated laboratory analyzer following CLSI standards.
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Baseline and 3 weeks (end of intervention)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Red blood cell count
Tidsramme: Baseline and 3 weeks (end of intervention)
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Venous blood erythrocyte concentration (×10⁶ cells/mm³) measured at baseline and 3 days after completion of the 3-week intervention.
Blood samples collected in the morning (08:00-10:00 h) after overnight fast (≥8 h) and 10 min of seated rest, analyzed by automated laboratory analyzer following CLSI standards.
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Baseline and 3 weeks (end of intervention)
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Hematocrit
Tidsramme: Baseline and 3 weeks (end of intervention)
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Percentage of red blood cells in total blood volume (%) measured at baseline and 3 days after completion of the 3-week intervention.
Blood samples collected under identical conditions to primary outcome measure.
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Baseline and 3 weeks (end of intervention)
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Serum ferritin
Tidsramme: Baseline and 3 weeks (end of intervention)
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Serum ferritin concentration (ng/mL) as an indicator of iron storage status, measured at baseline and 3 days after completion of the 3-week intervention.
Obtained from serum separator tubes analyzed by automated laboratory analyzer following CLSI standards.
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Baseline and 3 weeks (end of intervention)
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Reticulocyte count
Tidsramme: Baseline and 3 weeks (end of intervention)
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Percentage of reticulocytes (immature red blood cells) in peripheral blood (%), used as an indirect indicator of erythropoietic activity.
Measured at baseline and 3 days after completion of the 3-week intervention under identical sampling conditions.
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Baseline and 3 weeks (end of intervention)
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Enrique Roche, Full Professor, University Miguel Hernández of Elche
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Metaboliske sygdomme
- Tegn og symptomer, luftveje
- Patologiske tilstande, tegn og symptomer
- Ernæringsmæssige og metaboliske sygdomme
- Tegn og symptomer
- Hypoxi
- Forstyrrelser i jernmetabolisme
- Undersøgelsesteknikker
- Epidemiologisk forskningsdesign
- Epidemiologiske metoder
- Forskningsdesign
- Metoder
- Kontrolgrupper
Andre undersøgelses-id-numre
- PS09/01093
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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The Jerzy Kukuczka Academy of Physical Education...Ministry of Science and Higher Education, PolandTilmelding efter invitationStrenght-træning med høj intensitet i Normoxia (H-N) | Lavintensiv strengenuddannelse i Normoxia (L-N) | Strenght-træning med høj intensitet i normobarisk hypoxia (H-H) | Lavintensiv strenght-træning i normobarisk hypoxia (L-H)Polen
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