Effect of Altitude on Iron Absorption in Iron Depleted Women

NCT05500014 | Active Not Recruiting

• 1 other identifier: 2022/01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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

Iron Deficiency Anemia; Iron Deficiency (Without Anemia); Altitude Hypoxia

Keywords

iron absorption; iron status; iron biofortification; Altitude and iron metabolism

Outcome Measures

Primary Outcomes (1)

• Iron absorption

  Iron absorption will be assessed by measuring the shift in the iron isotopic composition in red blood cells, 14 days after the last test meal administration. Iron absoroption will be expressed as percentage of the total dose administered in the test meals (%)

  3 weeks

Secondary Outcomes (4)

• Serum ferritin (SF)

  5 minutes (combined with other biochemical assessements)

• soluble transferrin receptor (sTfR)

  5 minutes (combined with other biochemical assessements)

• C-Reactive Protein (CRP)

  5 minutes (combined with other biochemical assessements)

• alpha acid glycoprotein (AGP)

  5 minutes (combined with other biochemical assessements)

Other Outcomes (3)

• Socioeconomic, diet and physical activity

  1 hour

• Erytropoietin

  5 minutes (combined with other biochemical assessements)

• Erythroferrone

  5 minutes (combined with other biochemical assessements)

Study Arms (1)

Biofortified potato

EXPERIMENTAL

500 g of biofortified, cooked potato, comsumed over 5 consecutive days (500g for each day, for a total of 2500 g of cooked potato). Potato meals will be labelled with a total of 3 mg 57FeSO4.

Other: Biofortified potato, not genetically modified

Interventions

Biofortified potato, not genetically modified OTHER

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

Also known as: Potato test meals

Biofortified potato

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy women aged 18-40 years
• Able to understand study requirements and provide written informed consent.
• Huancavelica study site: having been a Huancavelica or Peruvian highlands resident in the last 5 years, with at least one parent being from Huancavelica
• Lima study site: having been a Lima resident in the last 5 years, with origins and at least one parent being from the Peruvian highlands (\>3000 masl)
• Serum ferritin at screening \< 30 microgram/L

You may not qualify if:

• Illness that affects the nutritional status or food intake: gastrointestinal or renal problems; self-reported metabolic disease based on prior diagnosis, or a prior screening questionnaire.
• Pregnancy (positive urine test).
• Currently breastfeeding.
• Allergy to any ingredients of the test meal.
• C-reactive protein \>5mg/100ml (representing inflammation)
• Smoker (\>1 cigarette per day)

Sponsors & Collaborators

• Swiss Distance University of Applied Sciences: lead
• ETH Zurich (Switzerland): collaborator
• Instituto de Investigacion Nutricional, Peru: collaborator

Study Sites (2)

Instituto International Nutrition

Huancavelica, Peru

Location

Insituto National de Nutrition

Lima, Peru

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Iron Deficiencies; Altitude Sickness

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Diego Moretti, PhD

  Swiss Distance University of Applied Sciences

  PRINCIPAL INVESTIGATOR

• Maria-Reyna Liria, PhD

  Insituto Investigation Nutritional

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: August 12, 2022
• Study Start: August 20, 2022
• Primary Completion: February 1, 2023
• Study Completion: April 30, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Locations

PE (2)