Iron Absorption From Encapsulated Iron Sulphate in Microspheres

NCT03332602 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-08-31

No results posted yet for this study

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.

Conditions

  • Iron-deficiency

Interventions

DIETARY_SUPPLEMENT

free FeSO4

Testmeal with free FeSO4

DIETARY_SUPPLEMENT

free FeSO4 and empty microspheres

Testmeal with free FeSO4 and empty micropsheres

DIETARY_SUPPLEMENT

free FeSO4 and hylauronic acid

Testmeal with free FeSO4 and hyaluronic acid

DIETARY_SUPPLEMENT

free FeSO4 and eudragit polymer

Testmeal with free FeSO4 and eudragit polymer

DIETARY_SUPPLEMENT

encapsulated FeSO4 3.2%

Testmeal with encapsulated FeSO4 with 3.2% Fe loading

DIETARY_SUPPLEMENT

encapsulated FeSO4 20%

Testmeal with encapsulated FeSO4 with 20% Fe loading

DIETARY_SUPPLEMENT

encapsulated FeSO4 3.2%, encapsulated Vitamin A

Testmeal with encapsulated FeSO4 with 3.2% Fe loading, and encapsulated Vitamin A

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

FeSO4 embedded in Hyaluronic acid

Testmeal with FeSO4 embedded in Hyaluronic acid

Sponsors & Collaborators

  • Swiss Federal Institute of Technology

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-04
Primary Completion
2018-07-18
Completion
2018-08-20

Countries

  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03332602 on ClinicalTrials.gov