Iron Bioavailability From Encapsulated Ferrous Sulphate

NCT ID: NCT02353325

Last Updated: 2017-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2016-06-30

Brief 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).

Conditions

Iron Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

non-encapsulated FeSO4

Maize porridge with salt fortified with non-encapsulated FeSO4

Group Type: EXPERIMENTAL

non-encapsulated FeSO4

Intervention Type: DIETARY_SUPPLEMENT

encapsulated FeSO4, before cooking

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

Group Type: EXPERIMENTAL

encapsulated FeSO4, before cooking

Intervention Type: DIETARY_SUPPLEMENT

encapsulated FeSO4, after cooking

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

Group Type: EXPERIMENTAL

encapsulated FeSO4, after cooking

Intervention Type: DIETARY_SUPPLEMENT

non-encapsulated FeSO4 + ascorbic acid

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

Group Type: EXPERIMENTAL

non-encapsulated FeSO4 + ascorbic acid

Intervention Type: DIETARY_SUPPLEMENT

encapsulated FeSO4 + ascorbic acid, before cooking

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

Group Type: EXPERIMENTAL

encapsulated FeSO4 + ascorbic acid, before cooking

Intervention Type: DIETARY_SUPPLEMENT

encapsulated FeSO4 + ascorbic acid, after cooking

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

Group Type: EXPERIMENTAL

encapsulated FeSO4 + ascorbic acid, after cooking

Intervention Type: DIETARY_SUPPLEMENT

Interventions

non-encapsulated FeSO4

Intervention Type: DIETARY_SUPPLEMENT

encapsulated FeSO4, before cooking

Intervention Type: DIETARY_SUPPLEMENT

encapsulated FeSO4, after cooking

Intervention Type: DIETARY_SUPPLEMENT

non-encapsulated FeSO4 + ascorbic acid

Intervention Type: DIETARY_SUPPLEMENT

encapsulated FeSO4 + ascorbic acid, before cooking

Intervention Type: DIETARY_SUPPLEMENT

encapsulated FeSO4 + ascorbic acid, after cooking

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Swiss Federal Institute of Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Human Nutrition Laboratory, ETH Zurich

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

Omnisalt

Identifier Type: -

Identifier Source: org_study_id