Iron Bioavailability From Encapsulated Ferrous Sulphate

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02353325
• Date of registration: 28/01/2015
• Prospective Registration: Yes
• Primary sponsor: Swiss Federal Institute of Technology
• Public title: Iron Bioavailability From Encapsulated Ferrous Sulphate
• Scientific title: Iron Bioavailability From Salt Fortified With Ferrous Sulphate, Zinc Sulphate and Ascorbic Acid Encapsulated in a Polymer Jacket
• Date of first enrolment: March 2016
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02353325
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Prevention. Masking: Single (Participant).
• Phase: N/A

Countries of recruitment

Switzerland

Key inclusion & exclusion criteria

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)



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Iron Deficiency

Intervention(s)

Dietary Supplement: non-encapsulated FeSO4

Dietary Supplement: non-encapsulated FeSO4 + ascorbic acid

Dietary Supplement: encapsulated FeSO4, after cooking

Dietary Supplement: encapsulated FeSO4 + ascorbic acid, before cooking

Dietary Supplement: encapsulated FeSO4, before cooking

Dietary Supplement: encapsulated FeSO4 + ascorbic acid, after cooking

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]

Secondary ID(s)

Omnisalt

Source(s) of Monetary Support

Please refer to primary and secondary sponsors