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Note: This record shows only 21 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 10 September 2018
Main ID:  NCT03332602
Date of registration: 18/10/2017
Prospective Registration: Yes
Primary sponsor: Swiss Federal Institute of Technology
Public title: Iron Absorption From Encapsulated Iron Sulphate in Microspheres
Scientific title: The Effect of Encapsulation Material and Encapsulated Micronutrients on Iron Absorption in Iron Depleted Women Consuming Iron Fortified Bread.
Date of first enrolment: April 4, 2018
Target sample size: 24
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03332602
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Prevention. Masking: Single (Participant).  
Phase:  N/A
Countries of recruitment
Switzerland
Contacts
Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Iron-deficiency
Intervention(s)
Dietary Supplement: encapsulated FeSO4 20%
Dietary Supplement: encapsulated FeSO4 3.2%
Dietary Supplement: encapsulated FeSO4 3.2%, encapsulated Vitamin A
Dietary Supplement: encapsulated FeSO4 3.2%, encapsulated Vitamin A, free Folic Acid
Dietary Supplement: FeSO4 embedded in Hyaluronic acid
Dietary Supplement: free FeSO4
Dietary Supplement: free FeSO4 and empty microspheres
Dietary Supplement: free FeSO4 and eudragit polymer
Dietary Supplement: free FeSO4 and hylauronic acid
Primary Outcome(s)
Change from baseline in the isotopic ratio of iron in blood at week 2 [Time Frame: baseline, 2 weeks]
Change from week 2 in the isotopic ratio of iron in blood at week 4 [Time Frame: 2 weeks, 4 weeks]
Change from week 4 in the isotopic ratio of iron in blood at week 6 [Time Frame: 4 weeks, 6 weeks]
Secondary Outcome(s)
Haemoglobin [Time Frame: baseline, weeks 2, 4 and 6]
inflammation marker [Time Frame: baseline, weeks 2, 4 and 6]
Plasma Ferritin [Time Frame: baseline, weeks 2, 4 and 6]
Secondary ID(s)
Omnifortificant
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
URL:
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