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Iron Bioavailability From Encapsulated Ferrous Sulphate

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ClinicalTrials.gov Identifier: NCT02353325
Recruitment Status : Completed
First Posted : February 2, 2015
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):
Swiss Federal Institute of Technology

Tracking Information
First Submitted Date  ICMJE January 28, 2015
First Posted Date  ICMJE February 2, 2015
Last Update Posted Date June 12, 2017
Actual Study Start Date  ICMJE March 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2015)
  • Change from baseline in the isotopic ratio of iron in blood at week 2 [ Time Frame: 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 [ Time Frame: 2 weeks, 4 weeks ]
    The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Iron Bioavailability From Encapsulated Ferrous Sulphate
Official Title  ICMJE Iron Bioavailability From Salt Fortified With Ferrous Sulphate, Zinc Sulphate and Ascorbic Acid Encapsulated in a Polymer Jacket
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Iron Deficiency
Intervention  ICMJE
  • Dietary Supplement: non-encapsulated FeSO4
  • Dietary Supplement: encapsulated FeSO4, before cooking
  • Dietary Supplement: encapsulated FeSO4, after cooking
  • Dietary Supplement: non-encapsulated FeSO4 + ascorbic acid
  • Dietary Supplement: encapsulated FeSO4 + ascorbic acid, before cooking
  • Dietary Supplement: encapsulated FeSO4 + ascorbic acid, after cooking
Study Arms  ICMJE
  • Experimental: non-encapsulated FeSO4
    Maize porridge with salt fortified with non-encapsulated FeSO4
    Intervention: Dietary Supplement: non-encapsulated FeSO4
  • Experimental: encapsulated FeSO4, before cooking
    Maize porridge with salt fortified with non-encapsulated FeSO4, added before cooking
    Intervention: Dietary Supplement: encapsulated FeSO4, before cooking
  • Experimental: encapsulated FeSO4, after cooking
    Maize porridge with salt fortified with non-encapsulated FeSO4, added after cooking
    Intervention: Dietary Supplement: encapsulated FeSO4, after cooking
  • Experimental: non-encapsulated FeSO4 + ascorbic acid
    Maize porridge with salt fortified with non-encapsulated FeSO4 and ascorbic acid
    Intervention: Dietary Supplement: non-encapsulated FeSO4 + ascorbic acid
  • Experimental: encapsulated FeSO4 + ascorbic acid, before cooking
    Maize porridge with salt fortified with non-encapsulated FeSO4 and ascorbic acid, added before cooking
    Intervention: Dietary Supplement: encapsulated FeSO4 + ascorbic acid, before cooking
  • Experimental: encapsulated FeSO4 + ascorbic acid, after cooking
    Maize porridge with salt fortified with non-encapsulated FeSO4 and ascorbic acid, added after cooking
    Intervention: Dietary Supplement: encapsulated FeSO4 + ascorbic acid, after cooking
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 28, 2015)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02353325
Other Study ID Numbers  ICMJE Omnisalt
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Swiss Federal Institute of Technology
Study Sponsor  ICMJE Swiss Federal Institute of Technology
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Swiss Federal Institute of Technology
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP