RecruitingNot ApplicableNCT07142590

Determination of Iron Absorption and Losses in People Living at High Altitude to Investigate the Requirements in This Population Group Using a Newly Developed Technique

Iron Balance in Humans Living at High Altitude: Defining Requirements and Optimal Biomarker Thresholds Using a Novel Body Iron Labelling Technique Based on Stable Iron Isotopes.


Sponsor

Diego Moretti

Enrollment

120 participants

Start Date

Aug 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Iron is an essential micronutrient responsible for a whealth of biological processes of the human body. Iron plays a fundamental role especially in oxygen transport, by binding to hemoglobin in the blood circulation. Iron intake from the diet needs to be in balance the unavoidable losses that occur daily via different pathways. The recommended daily requirement of iron is based on the balance between absorption and losses and is calculated to maintain a balance so that the absorption equals losses. At higher altitudes, the absorption of iron may be higher due to adaptation mechanisms in response to low oxygen concentration, and to maintain a larger erytroid compartement. However, the long-term effects of altitude on iron balance are unknown. Filling this knowledge gap is important to better understand iron deficiency in populations living at high and moderate altitudes. Therefore, the investigators plan to study people that live at two different altitudes and measure iron absorption and losses over the long term. This will be useful to formulate specific recommendations for this population groups, to expand the knowledge base to better prevent iron deficiency in Switzerland but also worldwide. Participants will be asked to consume a dose of stable iron isotopes. After one year from isotope administration, the isotopes will be equally distributed in all body compartments and any change in the isotope abundance with the normal occurring body iron can be detected. From this point onwards, the investigators can observe the iron turnover and calculate iron absorption and losses per unit of time. At 4 different visits blood samples will be taken from each participant.


Eligibility

Min Age: 18 YearsMax Age: 45 Years

Inclusion Criteria5

  • Females and males aged 18-45 y
  • BMI: 18 to 25 kg/m2
  • Body weight \<70 kg for females, \<85 kg for males
  • Plasma ferritin \>25 µg/L
  • Signed informed consent

Exclusion Criteria18

  • Hb \<12 g/dL (females), Hb \<13 g/dL (males), corrected for altitude using the 2024 WHO guidance values for hemoglobin adjustments
  • Inflammation (CRP \> 5 mg/L)1
  • Plasma ferritin \>150 µg/L for females and \>200 µg/L for males
  • Chronic disease known to affect iron metabolism
  • Chronic medications (except for oral contraceptives)
  • Pregnancy (tested at screening) or intention to become pregnant during the course of the study
  • Lactation
  • High physical activity (MET-min/week \> 3000 calculated according to the IPAQ, short version, administered at the screening)
  • Difficulty with blood withdrawal
  • Earlier participation in a study using stable iron isotopes or participation in any clinical study within the last 30 days
  • Smoking
  • Blood donation, blood transfusion or significant blood loss (more than 400 mL) over the past 6 months
  • Intention to regularly donate blood during the 2 years duration of the study
  • No residence in the respective location/altitude for at least the last 2 years
  • No intention to reside in the respective location/altitude at least for the next 2 years
  • Participants who are planning to spend an extended period (\>12 weeks) at a different altitude from their residence location
  • Spending more than 2 nights per week at a different location from residence location
  • Inability to understand the information sheet and the informed consent form due to cognitive or language reasons

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Interventions

DIETARY_SUPPLEMENTStable Isotopes

15 mg of stable iron isotopes in the form of ferrous sulphate 57FeSO4 will be orally administered to each participant.


Locations(1)

Fernfachhochschule Schweiz (FFHS)

Zurich, Canton of Zurich, Switzerland

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NCT07142590


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