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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorDiego Moretti

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Stable Isotopes

    Dietary supplement

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

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Isotopic labeled participantsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

57Fe tracer concentration in the circulation

The measurement of the isotopic tracer concentration in the circulation allows to calculate the lon-term iron absorption in the participants, and the rate of change of the tracer allows to calculate the rate of change of body iron.

Time frame
1 year after isotopic administration and every four months afterwards, for a total of 4 measurements.

Secondary outcomes

1

Hemoglobin mass

Hemoglobin mass will be measured using the CO-rebreathing method. In contrast to hemoglobin concentration, hemoglobin mass is more accurate since it does not depend on blood volume.

Time frame
1 year after isotopic administration and every four months afterwards, for a total of 2 measurements for each participant.
2

Ferritin concentration

Ferritin concentration in serum, expressed as ug/L will be assessed as an indicator of the iron status.

Time frame
1 year after isotopic administration and every four months afterwards, for a total of 4 measurements.
3

Hepcidin concentration

Hepcidin concentration in serum will be measured as a parameter for the iron status.

Time frame
1 year after isotopic administration and every four months afterwards, for a total of 4 measurements.
4

Serum transferrin receptor concentration

The serum concentration of the transferrin receptor (TfR) will be measure as a biomarker for iron status.

Time frame
1 year after isotopic administration and every four months afterwards, for a total of 4 measurements.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Diego Moretti

Lead sponsor

Swiss Distance University of Applied Sciences

Sponsor institution

Swiss Federal Institute of Technology

Collaborator

University of Lausanne

Collaborator