NCT07142590

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Diego Moretti · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study compares iron absorption in two population groups residing at different altitudes in Switzerland-one below 1000 meters above sea level and the other above 1500 meters. Additionally, the study aims to determine whether daily iron intake recommendations should be adjusted for high-altitude populations and to establish appropriate thresholds for diagnosing iron deficiency and iron deficiency anemia in these conditions. In each group 60 participants (30 men and 30 women) will be recruited. Each participant will be administered with an oral dose of iron isotopes in the form of ferrous sulphate 57FeSO4 dissolved in water. Ascorbic acid (vitamin C) will be additionally given with the isotope dose to increase the absorption and the enrichment in the body compartments and sirup will be added to the solution to confer a sweet flavour. There will be no other intervention throughout the course of the study. The investigators will collect blood samples during the second year from study start at a frequency of 4 months for a total of 4 visits, at months 12, 16, 20 and 24. Venous blood samples for the measurement of the isotopic signal will be collected, and at two additional study visits the investigators will also measure hemoglobin using the so-called carbon monoxide (CO) rebreathing method that includes a CO rebreathing into a closed-circuit system in combination with pure oxygen. Before and after the 6 min re-breathing, capillary blood will be collected by finger prick in triplicates. At the study visits with blood withdrawal, the investigators will ask participants to fill questionnaires about dietary intake and physical activity.

Conditions

• Iron Absorption
• Iron Requirements
• Altitude

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Stable Isotopes	15 mg of stable iron isotopes in the form of ferrous sulphate 57FeSO4 will be orally administered to each participant.

Timeline

• Start date: 2025-08-22
• Primary completion: 2028-02-01
• Completion: 2028-02-01
• First posted: 2025-08-26
• Last updated: 2026-01-14

Locations

1 site across 1 country: Switzerland