Iron Absorption From Encapsulated Iron Sulphate in Microspheres

Federal Institute of Technology (ETH) Zurich

Status: Completed

Conditions: Iron-deficiency

Treatments: Dietary Supplement: free FeSO4 and hylauronic acid; Dietary Supplement: encapsulated FeSO4 20%; Dietary Supplement: free FeSO4; Dietary Supplement: free FeSO4 and eudragit polymer; Dietary Supplement: encapsulated FeSO4 3.2%; Dietary Supplement: free FeSO4 and empty microspheres; Dietary Supplement: encapsulated FeSO4 3.2%, encapsulated Vitamin A; Dietary Supplement: FeSO4 embedded in Hyaluronic acid; Dietary Supplement: encapsulated FeSO4 3.2%, encapsulated Vitamin A, free Folic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT03332602

Omnifortificant

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

24 participants in 9 patient groups

free FeSO4

Experimental group

Description:

wheat bread fortified with free FeSO4

Treatment:

Dietary Supplement: free FeSO4

free FeSO4 and empty microspheres

Experimental group

Description:

wheat bread fortified with free FeSO4, and empty microspheres

Treatment:

Dietary Supplement: free FeSO4 and empty microspheres

free FeSO4 with eudragit polymer

Experimental group

Description:

wheat bread fortified with free FeSO4, and eudragit polymer

Treatment:

Dietary Supplement: free FeSO4 and eudragit polymer

free FeSO4 with Hyaluronic Acid

Experimental group

Description:

wheat bread fortified with free FeSO4, and hyaluronic acid

Treatment:

Dietary Supplement: free FeSO4 and hylauronic acid

encapsulated FeSO4 3.2%

Experimental group

Description:

wheat bread fortified with encapsulated FeSO4 in a microsphere with 3.2% Fe loading

Treatment:

Dietary Supplement: encapsulated FeSO4 3.2%

encapsulated FeSO4 20%

Experimental group

Description:

wheat bread fortified with encapsulated FeSO4 in a microsphere with 20% Fe loading

Treatment:

Dietary Supplement: encapsulated FeSO4 20%

encapsulated FeSO4 3.2%, encap. Vitamin A

Experimental group

Description:

wheat bread fortified with encapsulated FeSO4 in a microsphere with 3.2% Fe loading, and encapsulated Vitamin A as microspheres

Treatment:

Dietary Supplement: encapsulated FeSO4 3.2%, encapsulated Vitamin A

encapsulated FeSO4 3.2%, encap. Vitamin A, free folicacid

Experimental group

Description:

wheat bread fortified with encapsulated FeSO4 as microsphere with 3.2% Fe loading, encapsulated Vitamin A as microspheres and free folic acid

Treatment:

Dietary Supplement: encapsulated FeSO4 3.2%, encapsulated Vitamin A, free Folic Acid

FeSO4 embedded in Hyaluronic Acid

Experimental group

Description:

wheat bread fortified with FeSO4 that is embedded in hyaluronic acid.

Treatment:

Dietary Supplement: FeSO4 embedded in Hyaluronic acid