Iron Bioavailability From Encapsulated Ferrous Sulphate

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

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).

Study Overview

• Status: Completed
• Conditions: Iron Deficiency
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8092
    • Human Nutrition Laboratory, ETH Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in the isotopic ratio of iron in blood at week 2	The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.	baseline, 2 weeks
Change from week 2 in the isotopic ratio of iron in blood at week 4	The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.	2 weeks, 4 weeks

Collaborators and Investigators

• Sponsor: Swiss Federal Institute of Technology

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: January 28, 2015
• First Submitted That Met QC Criteria: January 28, 2015
• First Posted (Estimate): February 2, 2015

Study Record Updates

• Last Update Posted (Actual): June 12, 2017
• Last Update Submitted That Met QC Criteria: June 9, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Iron deficiency; Iron fortification; Iron encapsulation
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Protective Agents; Micronutrients; Vitamins; Antioxidants; Ascorbic Acid; Fesoterodine
• Other Study ID Numbers: Omnisalt