Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
All Genders
Healthy Volunteers
ID07142590

Iron Balance in Humans Living at High Altitude Using Stable Iron Isotopes to Define Requirements and Biomarker Thresholds

Led by Diego Moretti · Updated on 2026-01-14

120

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

D

Diego Moretti

Lead Sponsor

S

Swiss Federal Institute of Technology

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating how living at different altitudes affects iron absorption and losses in the body. The study focuses on people living below 1000 meters and above 1500 meters in Switzerland to better understand if daily iron intake recommendations and diagnostic thresholds for iron deficiency anemia should be adjusted for high-altitude populations. The study enrolls healthy adults aged 18 to 45 to fill knowledge gaps regarding iron balance influenced by oxygen availability at altitude. Participants will receive a single oral dose of stable iron isotopes (15 mg of ferrous sulphate 57FeSO4) combined with vitamin C and syrup to improve absorption and taste. The two groups differ only by their residence altitude, with no other interventions applied. The study includes a long-term observation period where iron turnover is tracked through isotope measurements in blood samples taken at four visits over the second year following isotope administration. During the four visits at months 12, 16, 20, and 24, blood samples will be collected to measure isotope concentration and several iron-related biomarkers including hemoglobin mass, ferritin, hepcidin, transferrin receptor, CRP, AGP, erythropoietin, and erythroferrone. Hemoglobin mass will be measured twice using a carbon monoxide rebreathing method. Participants will also complete questionnaires on diet and physical activity. This comprehensive monitoring aims to determine iron absorption, losses, and the impact of altitude on iron balance over time.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 45Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Females and males aged 18-45 years
  • Body mass index (BMI) between 18 and 25 kg/m2
  • Body weight less than 70 kg for females and less than 85 kg for males
  • Plasma ferritin greater than 25 �b5g/L
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Hemoglobin less than 12 g/dL for females or less than 13 g/dL for males, adjusted for altitude
  • Evidence of inflammation with CRP greater than 5 mg/L
  • Plasma ferritin greater than 150 �b5g/L for females or greater than 200 �b5g/L for males
  • Chronic diseases affecting iron metabolism
  • Use of chronic medications except oral contraceptives
  • Pregnancy or planning pregnancy during the study
  • Breastfeeding
  • High physical activity exceeding 3000 MET-min/week
  • Difficulty with blood withdrawal
  • Participation in a stable iron isotope study or other clinical study within the last 30 days
  • Smoking
  • Blood donation, transfusion, or significant blood loss over 400 mL in the past 6 months
  • Intending to donate blood regularly during the 2-year study
  • Not living at the study altitude location for at least 2 years or not planning to remain there for 2 years
  • Planning to spend more than 12 weeks at a different altitude during the study
  • Spending more than 2 nights per week away from residence location
  • Inability to understand study information due to cognitive or language barriers

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 day

Participants receive a single oral dose of stable iron isotopes (ferrous sulphate 57FeSO4) with vitamin C to assess iron absorption. There is no other intervention throughout the study.

1 visit (in-person)

Monitoring

Duration - 12 months

Participants undergo blood sample collections and assessments to measure iron tracer concentration, hemoglobin mass, and other iron-related biomarkers. Questionnaires about dietary intake and physical activity are completed during some visits.

4 visits (in-person) at months 12, 16, 20, and 24

Trial Site Locations

Total: 1 location

1

Fernfachhochschule Schweiz (FFHS)

Zurich, Canton of Zurich, Switzerland, 8005

Actively Recruiting

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Research Team

N

Nora Barloggio

D

Diego Moretti, Prof. Dr.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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