Effect of Altitude on Iron Absorption in Iron Depleted Women

NCT05500014 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-04-17

No results posted yet for this study

Summary

One of the most common nutritional deficiencies worldwide is iron deficiency. Iron deficiency is considered the main cause of anaemia in developing countries, including those in South America. The most recent surveys report that the prevalence of anaemia is as high as, 40 and 25% in Peru.

Populations living at higher altitudes may have higher iron requirements, as body iron is naturally increased in long-term high-altitude residents to compensate for the lower oxygen in the air at high altitudes. However, the effects of chronic exposure to high altitude on iron status, body iron compartments and dietary iron requirements are incompletely understood.

The primary objective of the proposed research is to determine iron bioavailability of iron from biofortified potatoes at different altitudes in populations of Andean descent. Human trials will be undertaken with volunteers in the Huancavelica region of Peru (elevation: 3676 meters) as well as in Lima (elevation close to sea level). The aim is to assess the effect of altitude on the absorption from a promising iron biofortified potato cultivar. These trials require incorporation of iron stable isotopes into the meals of the bio fortified potato and the analysis of the isotopes in subsequent blood (red blood cells) samples. Stable iron istotopes are considered the golden standard to assess human iron absorption and can be safely used as tracer substances in humans.

The objective of the study is to compare, in volunteer females of childbearing age, the bioavailability of iron from bio-fortified potatoes in two locations of different altitudes and quantify the effect of altitude on iron bioavailability from a potato meal consumed over 5 consecutive days.

Conditions

Interventions

OTHER

Biofortified potato, not genetically modified

Cooked potato, not genetically modified, with the addition of an acqueous solution of 57FeSO4 (3 mg in total).

Sponsors & Collaborators

  • ETH Zurich (Switzerland)

    collaborator OTHER
  • Instituto de Investigacion Nutricional, Peru

    collaborator OTHER
  • Swiss Distance University of Applied Sciences

    lead OTHER

Principal Investigators

  • Diego Moretti, PhD · Swiss Distance University of Applied Sciences

  • Maria-Reyna Liria, PhD · Insituto Investigation Nutritional

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-20
Primary Completion
2023-02-01
Completion
2024-04-30

Countries

  • Peru

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05500014 on ClinicalTrials.gov