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Iron Bioavailability From Encapsulated Ferrous Sulphate

Primary Purpose

Iron Deficiency

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
non-encapsulated FeSO4
encapsulated FeSO4, before cooking
encapsulated FeSO4, after cooking
non-encapsulated FeSO4 + ascorbic acid
encapsulated FeSO4 + ascorbic acid, before cooking
encapsulated FeSO4 + ascorbic acid, after cooking
Sponsored by
Swiss Federal Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Iron Deficiency focused on measuring Iron deficiency, Iron fortification, Iron encapsulation

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Human Nutrition Laboratory, ETH Zurich

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

non-encapsulated FeSO4

encapsulated FeSO4, before cooking

encapsulated FeSO4, after cooking

non-encapsulated FeSO4 + ascorbic acid

encapsulated FeSO4 + ascorbic acid, before cooking

encapsulated FeSO4 + ascorbic acid, after cooking

Arm Description

Maize porridge with salt fortified with non-encapsulated FeSO4

Maize porridge with salt fortified with non-encapsulated FeSO4, added before cooking

Maize porridge with salt fortified with non-encapsulated FeSO4, added after cooking

Maize porridge with salt fortified with non-encapsulated FeSO4 and ascorbic acid

Maize porridge with salt fortified with non-encapsulated FeSO4 and ascorbic acid, added before cooking

Maize porridge with salt fortified with non-encapsulated FeSO4 and ascorbic acid, added after cooking

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 28, 2015
Last Updated
June 9, 2017
Sponsor
Swiss Federal Institute of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT02353325
Brief Title
Iron Bioavailability From Encapsulated Ferrous Sulphate
Official Title
Iron Bioavailability From Salt Fortified With Ferrous Sulphate, Zinc Sulphate and Ascorbic Acid Encapsulated in a Polymer Jacket
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Federal Institute of Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency
Keywords
Iron deficiency, Iron fortification, Iron encapsulation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
non-encapsulated FeSO4
Arm Type
Experimental
Arm Description
Maize porridge with salt fortified with non-encapsulated FeSO4
Arm Title
encapsulated FeSO4, before cooking
Arm Type
Experimental
Arm Description
Maize porridge with salt fortified with non-encapsulated FeSO4, added before cooking
Arm Title
encapsulated FeSO4, after cooking
Arm Type
Experimental
Arm Description
Maize porridge with salt fortified with non-encapsulated FeSO4, added after cooking
Arm Title
non-encapsulated FeSO4 + ascorbic acid
Arm Type
Experimental
Arm Description
Maize porridge with salt fortified with non-encapsulated FeSO4 and ascorbic acid
Arm Title
encapsulated FeSO4 + ascorbic acid, before cooking
Arm Type
Experimental
Arm Description
Maize porridge with salt fortified with non-encapsulated FeSO4 and ascorbic acid, added before cooking
Arm Title
encapsulated FeSO4 + ascorbic acid, after cooking
Arm Type
Experimental
Arm Description
Maize porridge with salt fortified with non-encapsulated FeSO4 and ascorbic acid, added after cooking
Intervention Type
Dietary Supplement
Intervention Name(s)
non-encapsulated FeSO4
Intervention Type
Dietary Supplement
Intervention Name(s)
encapsulated FeSO4, before cooking
Intervention Type
Dietary Supplement
Intervention Name(s)
encapsulated FeSO4, after cooking
Intervention Type
Dietary Supplement
Intervention Name(s)
non-encapsulated FeSO4 + ascorbic acid
Intervention Type
Dietary Supplement
Intervention Name(s)
encapsulated FeSO4 + ascorbic acid, before cooking
Intervention Type
Dietary Supplement
Intervention Name(s)
encapsulated FeSO4 + ascorbic acid, after cooking
Primary Outcome Measure Information:
Title
Change from baseline in the isotopic ratio of iron in blood at week 2
Description
The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
Time Frame
baseline, 2 weeks
Title
Change from week 2 in the isotopic ratio of iron in blood at week 4
Description
The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
Time Frame
2 weeks, 4 weeks

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: 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)
Facility Information:
Facility Name
Human Nutrition Laboratory, ETH Zurich
City
Zurich
ZIP/Postal Code
8092
Country
Switzerland

12. IPD Sharing Statement

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Iron Bioavailability From Encapsulated Ferrous Sulphate

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