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Completed

NCT Number: NCT02353325

Iron Bioavailability From Encapsulated Ferrous Sulphate

Salt is one of the very few regularly purchased food item in all socioeconomic classes including poor remote areas with subsistence farming. Therefore, it is a promising vehicle for fortification with micronutrients, such as iodine, iron, vitamin A, to alleviate the burden of micronutrient deficiencies. However, ensuring the bioavailability of iron and the sensory quality in fortified salt is difficult. Water-soluble iron compounds, such as ferrous sulphate FeSO4, are the most bioavailable, but they react with moisture and impurities in salt, and cause unacceptable changes in colour. Encapsulation can reduce iron-mediated colour change in fortified salt without significantly compromise bioavailability. In the present project we aim to investigate the iron bioavailability from salt fortified with FeSO4 using a new encapsulation type based on hyaluronic acid (HA) and a polymer from the eudragit family (EPO).

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Key information

Conditions

Iron Deficiency Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Human Nutrition Laboratory, ETH Zurich

Zurich, 8092, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female, 18 to 40 years old
  • Marginal iron status (ferritin < 25 ng/ml)
  • Body weight < 65 kg
  • Normal body Mass Index (18.5 - 25 kg/m2)
  • Signed informed consent

Exclusion criteria

  • Pregnancy (assessed by a pregnancy test) / intention to become pregnant
  • Lactating up to 6 weeks before study initiation
  • Moderate or severe anaemia (hemoglobin < 9.0 g/dL)
  • Elevated C-reactive protein (> 5.0 mg/L)
  • Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement)
  • Continuous/long-term use of medication during the whole study (except for contraceptives)
  • Consumption of mineral and vitamin supplements within 2 weeks prior to 1st meal administration
  • Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months
  • Earlier participation in a study using Fe stable isotopes or participation in any clinical study within the last 30 days
  • Participant who cannot be expected to comply with study protocol (e.g. not available on certain study appointments or difficulties with blood sampling)

Treatment and study plan

non-encapsulated FeSO4

Dietary Supplement

encapsulated FeSO4, before cooking

Dietary Supplement

encapsulated FeSO4, after cooking

Dietary Supplement

non-encapsulated FeSO4 + ascorbic acid

Dietary Supplement

encapsulated FeSO4 + ascorbic acid, before cooking

Dietary Supplement

encapsulated FeSO4 + ascorbic acid, after cooking

Dietary Supplement

Primary outcomes

  1. Change from baseline in the isotopic ratio of iron in blood at week 2

    Time frame: baseline, 2 weeks

    The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.

  2. Change from week 2 in the isotopic ratio of iron in blood at week 4

    Time frame: 2 weeks, 4 weeks

    The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Registry information

Official study title

Iron Bioavailability From Salt Fortified With Ferrous Sulphate, Zinc Sulphate and Ascorbic Acid Encapsulated in a Polymer Jacket

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 2, 2015
Registry last updated
Jun 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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