Iron Bioavailability From Encapsulated Ferrous Sulphate

Not Applicable

Completed

• Conditions: Iron Deficiency
• Interventions: Dietary Supplement: encapsulated FeSO4, after cooking; Dietary Supplement: encapsulated FeSO4, before cooking; Dietary Supplement: non-encapsulated FeSO4; Dietary Supplement: encapsulated FeSO4 + ascorbic acid, before cooking; Dietary Supplement: non-encapsulated FeSO4 + ascorbic acid; Dietary Supplement: encapsulated FeSO4 + ascorbic acid, after cooking

• Registration Number: NCT02353325
• Lead Sponsor: Swiss Federal Institute of Technology

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-28
• Study First Submitted QC: 2015-01-28
• Study First Posted: 2015-02-02
• Study Start: 2016-03
• Primary Completion: 2016-05
• Study Completion: 2016-06
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-09
• Last Update Posted: 2017-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
encapsulated FeSO4, after cooking	encapsulated FeSO4, after cooking	Maize porridge with salt fortified with non-encapsulated FeSO4, added after cooking
encapsulated FeSO4, before cooking	encapsulated FeSO4, before cooking	Maize porridge with salt fortified with non-encapsulated FeSO4, added before cooking
non-encapsulated FeSO4	non-encapsulated FeSO4	Maize porridge with salt fortified with non-encapsulated FeSO4
encapsulated FeSO4 + ascorbic acid, before cooking	encapsulated FeSO4 + ascorbic acid, before cooking	Maize porridge with salt fortified with non-encapsulated FeSO4 and ascorbic acid, added before cooking
non-encapsulated FeSO4 + ascorbic acid	non-encapsulated FeSO4 + ascorbic acid	Maize porridge with salt fortified with non-encapsulated FeSO4 and ascorbic acid
encapsulated FeSO4 + ascorbic acid, after cooking	encapsulated FeSO4 + ascorbic acid, after cooking	Maize porridge with salt fortified with non-encapsulated FeSO4 and ascorbic acid, added after cooking

Primary Outcome Measures

Name	Time	Method
Change from baseline in the isotopic ratio of iron in blood at week 2	baseline, 2 weeks	The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
Change from week 2 in the isotopic ratio of iron in blood at week 4	2 weeks, 4 weeks	The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.

Trial Locations

Locations (1)

Human Nutrition Laboratory, ETH Zurich; 🇨🇭 Zurich, Switzerland