Iron Absorption From Encapsulated Iron Sulphate in Microspheres

Iron-deficiency Clinical Trial

Official title:

The Effect of Encapsulation Material and Encapsulated Micronutrients on Iron Absorption in Iron Depleted Women Consuming Iron Fortified Bread.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03332602
• Other study ID #: Omnifortificant
• Status: Completed
• Phase: N/A
• Start date: April 4, 2018
• Est. completion date: August 20, 2018

Study information

• Verified date: August 2018
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Food fortification has shown to be efficacious to alleviate the burden of micronutrient deficiencies. Ensuring the bioavailability of iron and maintaining the sensory quality and stability of the fortified food and other added micronutrients remains a challenge. Soluble iron compounds cause minor organoleptic changes in foods but their bioavailability in man is rather low. Water-soluble iron compounds, such as ferrous sulphate (FeSO4), are the compounds in which the iron is most bioavailable; however, they often cause unfavorable sensory changes.

Encapsulation of iron has excellent potential for overcoming unwanted sensory changes and iodine losses in salt, while maintaining acceptable bioavailability. In the present project, we would like to investigate the iron bioavailability from a new formulation of encapsulated iron sulphate based on hyaluronic acid (HA) and a polymer from the eudragit family.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 20, 2018
• Est. primary completion date: July 18, 2018
• 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 (PF <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 (Hb < 9.0 g/dL)

• Elevated C reactive Protein (CRP) (> 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:
• free FeSO4
Testmeal with free FeSO4
• free FeSO4 and empty microspheres
Testmeal with free FeSO4 and empty micropsheres
• free FeSO4 and hylauronic acid
Testmeal with free FeSO4 and hyaluronic acid
• free FeSO4 and eudragit polymer
Testmeal with free FeSO4 and eudragit polymer
• encapsulated FeSO4 3.2%
Testmeal with encapsulated FeSO4 with 3.2% Fe loading
• encapsulated FeSO4 20%
Testmeal with encapsulated FeSO4 with 20% Fe loading
• encapsulated FeSO4 3.2%, encapsulated Vitamin A
Testmeal with encapsulated FeSO4 with 3.2% Fe loading, and encapsulated Vitamin A
• encapsulated FeSO4 3.2%, encapsulated Vitamin A, free Folic Acid
Testmeal with encapsulated FeSO4 with 3.2% Fe loading, and encapsulated Vitamin A, with free folic acid.
• FeSO4 embedded in Hyaluronic acid
Testmeal with FeSO4 embedded in Hyaluronic acid

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
Primary	Change from week 4 in the isotopic ratio of iron in blood at week 6	The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.	4 weeks, 6 weeks
Secondary	Haemoglobin	Haemoglobin of each timepoint	baseline, weeks 2, 4 and 6
Secondary	Plasma Ferritin	Plasma Ferritin of each timepoint	baseline, weeks 2, 4 and 6
Secondary	inflammation marker	C reactive Protein of each timepoint	baseline, weeks 2, 4 and 6