Clinical trial NCT03332602: Iron Absorption From Encapsulated Iron Sulphate in Microspheres
Official title: The Effect of Encapsulation Material and Encapsulated Micronutrients on Iron Absorption in Iron Depleted Women Consuming Iron Fortified Bread.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron-deficiency
Keywords: Iron deficiency
Iron fortification
Iron encapsulation
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change from baseline in the isotopic ratio of iron in blood at week 2
timeFrame: baseline, 2 weeks
measure: Change from week 2 in the isotopic ratio of iron in blood at week 4
timeFrame: 2 weeks, 4 weeks
measure: Change from week 4 in the isotopic ratio of iron in blood at week 6
timeFrame: 4 weeks, 6 weeks
Secondary outcomes:
measure: Haemoglobin
timeFrame: baseline, weeks 2, 4 and 6
measure: Plasma Ferritin
timeFrame: baseline, weeks 2, 4 and 6
measure: inflammation marker
timeFrame: baseline, weeks 2, 4 and 6
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Human Nutrition Laboratory, ETH Zurich
Study officials:
References: