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Iron Bioavailability From Encapsulated Ferrous Sulphate

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ClinicalTrials.gov Identifier: NCT02353325
Recruitment Status : Completed
First Posted : February 2, 2015
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):
Swiss Federal Institute of Technology

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Iron Deficiency Dietary Supplement: 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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Iron Bioavailability From Salt Fortified With Ferrous Sulphate, Zinc Sulphate and Ascorbic Acid Encapsulated in a Polymer Jacket
Actual Study Start Date : March 2016
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron Vitamin C

Arms and Interventions
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Arm Intervention/treatment
Experimental: non-encapsulated FeSO4
Maize porridge with salt fortified with non-encapsulated FeSO4
 Dietary Supplement: non-encapsulated FeSO4
Experimental: encapsulated FeSO4, before cooking
Maize porridge with salt fortified with non-encapsulated FeSO4, added before cooking
 Dietary Supplement: encapsulated FeSO4, before cooking
Experimental: encapsulated FeSO4, after cooking
Maize porridge with salt fortified with non-encapsulated FeSO4, added after cooking
 Dietary Supplement: encapsulated FeSO4, after cooking
Experimental: non-encapsulated FeSO4 + ascorbic acid
Maize porridge with salt fortified with non-encapsulated FeSO4 and ascorbic acid
 Dietary Supplement: non-encapsulated FeSO4 + ascorbic acid
Experimental: encapsulated FeSO4 + ascorbic acid, before cooking
Maize porridge with salt fortified with non-encapsulated FeSO4 and ascorbic acid, added before cooking
 Dietary Supplement: encapsulated FeSO4 + ascorbic acid, before cooking
Experimental: encapsulated FeSO4 + ascorbic acid, after cooking
Maize porridge with salt fortified with non-encapsulated FeSO4 and ascorbic acid, added after cooking
 Dietary Supplement: encapsulated FeSO4 + ascorbic acid, after cooking


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02353325


Locations
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Switzerland
Human Nutrition Laboratory, ETH Zurich
Zurich, Switzerland, 8092
Sponsors and Collaborators
Swiss Federal Institute of Technology
More Information
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Responsible Party: Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT02353325    
Other Study ID Numbers: Omnisalt
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017
Keywords provided by Swiss Federal Institute of Technology:
Iron deficiency
Iron fortification
Iron encapsulation
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Ascorbic Acid
Fesoterodine
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
 Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Urological Agents