Iron Bioavailability From Encapsulated Ferrous Sulphate
Iron Bioavailability From Salt Fortified With Ferrous Sulphate, Zinc Sulphate and Ascorbic Acid Encapsulated in a Polymer Jacket
1 other identifier
interventional
20
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2015
CompletedFirst Posted
Study publicly available on registry
February 2, 2015
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJune 12, 2017
June 1, 2017
2 months
January 28, 2015
June 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from baseline in the isotopic ratio of iron in blood at week 2
The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
baseline, 2 weeks
Change from week 2 in the isotopic ratio of iron in blood at week 4
The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
2 weeks, 4 weeks
Study Arms (6)
non-encapsulated FeSO4
EXPERIMENTALMaize porridge with salt fortified with non-encapsulated FeSO4
encapsulated FeSO4, before cooking
EXPERIMENTALMaize porridge with salt fortified with non-encapsulated FeSO4, added before cooking
encapsulated FeSO4, after cooking
EXPERIMENTALMaize porridge with salt fortified with non-encapsulated FeSO4, added after cooking
non-encapsulated FeSO4 + ascorbic acid
EXPERIMENTALMaize porridge with salt fortified with non-encapsulated FeSO4 and ascorbic acid
encapsulated FeSO4 + ascorbic acid, before cooking
EXPERIMENTALMaize porridge with salt fortified with non-encapsulated FeSO4 and ascorbic acid, added before cooking
encapsulated FeSO4 + ascorbic acid, after cooking
EXPERIMENTALMaize porridge with salt fortified with non-encapsulated FeSO4 and ascorbic acid, added after cooking
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Human Nutrition Laboratory, ETH Zurich
Zurich, 8092, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2015
First Posted
February 2, 2015
Study Start
March 1, 2016
Primary Completion
May 1, 2016
Study Completion
June 1, 2016
Last Updated
June 12, 2017
Record last verified: 2017-06