Effect of Altitude on Iron Absorption in Iron Depleted Women

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Brief Title

Effect of Altitude on Iron Absorption in Iron Depleted Women

Official Title

Effect of Altitude on Iron Absorption in Iron Depleted Women

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.
    


Study Type

Interventional


Primary Outcome

Iron absorption

Secondary Outcome

 Serum ferritin (SF)

Condition

Iron Deficiency Anemia

Intervention

Biofortified potato, not genetically modified

Study Arms / Comparison Groups

 Biofortified potato
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

80

Start Date

August 20, 2022

Completion Date

December 31, 2022

Primary Completion Date

October 31, 2022

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)
      

Gender

Female

Ages

18 Years - 40 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Diego Moretti, PhD, +41 (0)44 512 09 20, [email protected]

Location Countries

Peru

Location Countries

Peru

Administrative Informations


NCT ID

NCT05500014

Organization ID

2022/01


Responsible Party

Sponsor

Study Sponsor

Swiss Distance University of Applied Sciences

Collaborators

 ETH Zurich (Switzerland)

Study Sponsor

Diego Moretti, PhD, Principal Investigator, Swiss Distance University of Applied Sciences


Verification Date

August 2022