Iron Bioavailability From Encapsulated Ferrous Sulphate

Iron Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02353325
• Other study ID #: Omnisalt
• Status: Completed
• Phase: N/A
• First received: January 28, 2015
• Last updated: June 9, 2017
• Start date: March 2016
• Est. completion date: June 2016

Study information

• Verified date: June 2017
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
Switzerland	Human Nutrition Laboratory, ETH Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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