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Effect of Altitude on Iron Absorption in Iron Depleted Women (PotatoAlt)

Primary Purpose

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

Status
Active
Phase
Not Applicable
Locations
Peru
Study Type
Interventional
Intervention
Biofortified potato, not genetically modified
Sponsored by
Swiss Distance University of Applied Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Iron Deficiency Anemia focused on measuring iron absorption, iron status, iron biofortification, Altitude and iron metabolism

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • Instituto International Nutrition
  • Insituto National de Nutrition

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biofortified potato

Arm Description

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.

Outcomes

Primary Outcome Measures

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 (%)

Secondary Outcome Measures

Serum ferritin (SF)
Is a proxy of iron stores will be measured in human serum at baseline and is expressed in micrograms /liter serum
soluble transferrin receptor (sTfR)
is expressed as mg/L human serum and will be assessed baseline
C-Reactive Protein (CRP)
is an inflammatory marker and will be assessed at baseline in human serum at baseline
alpha acid glycoprotein (AGP)
Is an inflammatory marker and will be assessed at baseline in human serum at baseline

Full Information

First Posted
July 11, 2022
Last Updated
April 11, 2023
Sponsor
Swiss Distance University of Applied Sciences
Collaborators
ETH Zurich (Switzerland), Instituto de Investigacion Nutricional, Peru
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1. Study Identification

Unique Protocol Identification Number
NCT05500014
Brief Title
Effect of Altitude on Iron Absorption in Iron Depleted Women
Acronym
PotatoAlt
Official Title
Effect of Altitude on Iron Absorption in Iron Depleted Women
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 20, 2022 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Distance University of Applied Sciences
Collaborators
ETH Zurich (Switzerland), Instituto de Investigacion Nutricional, Peru

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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 partial pressure. A residence altitude of 3600 masl implies an increase in Hemoglobin of ≈30 g Hb/l, which would correspond, in a 60 Kg woman to an increase of ≈500 mg red blood cell iron. Early studies in Bolivia have suggested decreased iron stores in women living at altitudes >3000 masl, compared to their counterparty living below 3000 masl . The short-term exposure to high altitudes has profound impacts on iron metabolism. The lower oxygen partial pressure increases the rate of red blood cell synthesis, which is reflected in decrease in iron status parameters such as serum iron, serum ferritin, and an increase in erythropoietin and erythroferrone which in turn downregulate hepcidin, the master regulator of systemic iron metabolism , affecting iron release from stores and dietary iron absorption . In addition, intracellular oxygen sensors, the prolyl hydrolases (PHD's), stabilize hypoxia inducible factors (HIF-1α and HIF2-α) critically controlling transcriptional regulators such as dimetal transporter-1 (DMT-1) responsible for apical iron absorption in enterocytes . Early studies in Peru by Huff et al. showed marked short-term increases of serum iron incorporation in red blood cells in subjects native from Lima (sea level) during acclimatization at Morococha, at 4540 masl. The opposite was the case in Morococha natives during acclimatization in Lima, as they had a decreased rate of plasma iron transfer to red blood cells . Notably however, during the short duration of the study (10 days) no marked change in red cell volume, hemoglobin or red cell mass could be detected. Despite these well-described biologic mechanisms and short-term effects on physiological markers of iron status, the effects of chronic exposure to high altitude on iron status, body iron compartments and dietary iron requirements are incompletely understood. Genetic factors as reflected by different ethnicities are considered to play a large role in altitude-induced adaptations in iron metabolism . A recent large study (n=71798) conducted in young male and iron replete Swiss army conscripts suggests a steady increase in hemoglobin and ferritin with increasing altitude, an increase that was detectable with each 300 masl increase, starting with as low as 300 masl of altitude. The authors also suggested that in this population, serum ferritin rose with altitude, independently from the increase in hemoglobin , suggesting a separate biological mechanism driving iron stores with increasing altitude. This data contrasts with data from Bolivia in apparently healthy women of reproductive age, where body iron stores were decreased at altitudes >3000 masl , compared to women living at lower altitudes (<3000 masl), suggesting that at high altitude, iron availability may be a limiting factor for optimal iron stores and for anemia prevention. More research is therefore needed on the determinants of iron balance in function of altitude, namely the interplay between dietary iron absorption, iron status, and iron status markers. 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 and the analysis of the isotopes in subsequent blood (red blood cells) samples.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia, Iron Deficiency (Without Anemia), Altitude Hypoxia
Keywords
iron absorption, iron status, iron biofortification, Altitude and iron metabolism

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Biofortified potato
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Biofortified potato, not genetically modified
Other Intervention Name(s)
Potato test meals
Intervention Description
Cooked potato, not genetically modified, with the addition of an acqueous solution of 57FeSO4 (3 mg in total).
Primary Outcome Measure Information:
Title
Iron absorption
Description
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 (%)
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Serum ferritin (SF)
Description
Is a proxy of iron stores will be measured in human serum at baseline and is expressed in micrograms /liter serum
Time Frame
5 minutes (combined with other biochemical assessements)
Title
soluble transferrin receptor (sTfR)
Description
is expressed as mg/L human serum and will be assessed baseline
Time Frame
5 minutes (combined with other biochemical assessements)
Title
C-Reactive Protein (CRP)
Description
is an inflammatory marker and will be assessed at baseline in human serum at baseline
Time Frame
5 minutes (combined with other biochemical assessements)
Title
alpha acid glycoprotein (AGP)
Description
Is an inflammatory marker and will be assessed at baseline in human serum at baseline
Time Frame
5 minutes (combined with other biochemical assessements)
Other Pre-specified Outcome Measures:
Title
Socioeconomic, diet and physical activity
Description
A questionnaire will be completed with the subjects to assess socioeconomic factors, dietary patterns and physical activity
Time Frame
1 hour
Title
Erytropoietin
Description
Is a marker of erytroid activity and will be measured in human serum at baseline
Time Frame
5 minutes (combined with other biochemical assessements)
Title
Erythroferrone
Description
Is a marker of erytroid activity and will be measured in human serum at baseline
Time Frame
5 minutes (combined with other biochemical assessements)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diego Moretti, PhD
Organizational Affiliation
Swiss Distance University of Applied Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria-Reyna Liria, PhD
Organizational Affiliation
Insituto Investigation Nutritional
Official's Role
Study Director
Facility Information:
Facility Name
Instituto International Nutrition
City
Huancavelica
Country
Peru
Facility Name
Insituto National de Nutrition
City
Lima
Country
Peru

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Effect of Altitude on Iron Absorption in Iron Depleted Women

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