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CompletedNCT07720960IHIT-IRONUpdated Jul 22, 2026

Effects of Intermittent Hypoxia Training With Iron Supplementation on Red Blood Cells and Iron Levels in Trained Athletes

An interventional study of Control group (CG) and Hypoxia group (HG): trained at simulated altitudes between 4,450 and 5,850 m in Hypoxia, Erythropoiesis and Iron Metabolism Disorders, sponsored by Néstor Vicente-Salar. Completed at 1 site in Spain. Open to male participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-22.

Sponsored by Néstor Vicente-Salar · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 14 years 8 months after the study started (first participant enrolled Oct 2011, registered Jul 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
Male
01

Study summary

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.

02

Conditions studied

  • Hypoxia
  • Erythropoiesis
  • Iron Metabolism Disorders
03

In context

Hypoxia

1,231 studies on the registry are indexed under Hypoxia; 241 are open to participants now.

This study's enrollment of 32 is below the median of 45 across 853 interventional studies indexed under Hypoxia.

Browse Hypoxia studies →

Lead sponsor

This is the only study on the registry with Néstor Vicente-Salar as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
32 participants (actual)

Study arms

  • Placebo comparator
    Control group (CG)

    Trained at sea-level conditions

    Other: Control group (CG)

  • Experimental
    Hypoxia group (HG)

    Trained at simulated altitudes between 4,450 and 5,850 m

    Other: Hypoxia group (HG): trained at simulated altitudes between 4,450 and 5,850 m

Interventions

  • OtherControl group (CG)

    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).

  • OtherHypoxia group (HG): trained at simulated altitudes between 4,450 and 5,850 m

    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).

06

What researchers measure

Primary outcomes

  1. Hemoglobin concentration

    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.

    Time frame: Baseline and 3 weeks (end of intervention)

Secondary outcomes

  1. Red blood cell count

    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.

    Time frame: Baseline and 3 weeks (end of intervention)

  2. Hematocrit

    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.

    Time frame: Baseline and 3 weeks (end of intervention)

  3. Serum ferritin

    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.

    Time frame: Baseline and 3 weeks (end of intervention)

  4. Reticulocyte count

    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.

    Time frame: Baseline and 3 weeks (end of intervention)

07

Study locations

1 site
  • University Miguel Hernández of Elche
    Elche, Alicante 03202, Spain
08

References and documents

Study documents

  • Informed consent form · Nov 26, 2014

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07720960
Lead sponsor
Néstor Vicente-Salar
Responsible party
Néstor Vicente-Salar (Asscociate Professor, Universidad Miguel Hernandez de Elche) — Sponsor-investigator
First posted
Jul 22, 2026
Start date
Oct 23, 2011
Primary completion
Jun 30, 2014
Completion
Jul 15, 2014
Last update
Jul 22, 2026

Study contacts

Enrique Roche, Full Professor
study director · University Miguel Hernández of Elche

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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