Iron Bioavailability From Encapsulated Ferrous Sulphate

Federal Institute of Technology (ETH) Zurich

Status: Completed

Conditions: Iron Deficiency

Treatments: Dietary Supplement: encapsulated FeSO4, before cooking; Dietary Supplement: encapsulated FeSO4 + ascorbic acid, before cooking; Dietary Supplement: non-encapsulated FeSO4; Dietary Supplement: non-encapsulated FeSO4 + ascorbic acid; Dietary Supplement: encapsulated FeSO4, after cooking; Dietary Supplement: encapsulated FeSO4 + ascorbic acid, after cooking

Study type: Interventional

Funder types: Other

Identifiers

NCT02353325

Omnisalt

Details and patient eligibility

About

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).

Enrollment: 20 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 6 patient groups

non-encapsulated FeSO4

Experimental group

Description:

Maize porridge with salt fortified with non-encapsulated FeSO4

Treatment:

Dietary Supplement: non-encapsulated FeSO4

encapsulated FeSO4, before cooking

Experimental group

Description:

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

Treatment:

Dietary Supplement: encapsulated FeSO4, before cooking

encapsulated FeSO4, after cooking

Experimental group

Description:

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

Treatment:

Dietary Supplement: encapsulated FeSO4, after cooking

non-encapsulated FeSO4 + ascorbic acid

Experimental group

Description:

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

Treatment:

Dietary Supplement: non-encapsulated FeSO4 + ascorbic acid

encapsulated FeSO4 + ascorbic acid, before cooking

Experimental group

Description:

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

Treatment:

Dietary Supplement: encapsulated FeSO4 + ascorbic acid, before cooking

encapsulated FeSO4 + ascorbic acid, after cooking

Experimental group

Description:

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

Treatment:

Dietary Supplement: encapsulated FeSO4 + ascorbic acid, after cooking