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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Iron Deficiency | 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 | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Prevention |
Official Title: | Iron Bioavailability From Salt Fortified With Ferrous Sulphate, Zinc Sulphate and Ascorbic Acid Encapsulated in a Polymer Jacket |
Actual Study Start Date : | March 2016 |
Actual Primary Completion Date : | May 2016 |
Actual Study Completion Date : | June 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: non-encapsulated FeSO4
Maize porridge with salt fortified with non-encapsulated FeSO4
|
Dietary Supplement: non-encapsulated FeSO4 |
Experimental: encapsulated FeSO4, before cooking
Maize porridge with salt fortified with non-encapsulated FeSO4, added before cooking
|
Dietary Supplement: encapsulated FeSO4, before cooking |
Experimental: encapsulated FeSO4, after cooking
Maize porridge with salt fortified with non-encapsulated FeSO4, added after cooking
|
Dietary Supplement: encapsulated FeSO4, after cooking |
Experimental: non-encapsulated FeSO4 + ascorbic acid
Maize porridge with salt fortified with non-encapsulated FeSO4 and ascorbic acid
|
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
|
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
|
Dietary Supplement: encapsulated FeSO4 + ascorbic acid, after cooking |
- 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.

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Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02353325
Switzerland | |
Human Nutrition Laboratory, ETH Zurich | |
Zurich, Switzerland, 8092 |
Responsible Party: | Swiss Federal Institute of Technology |
ClinicalTrials.gov Identifier: | NCT02353325 |
Other Study ID Numbers: |
Omnisalt |
First Posted: | February 2, 2015 Key Record Dates |
Last Update Posted: | June 12, 2017 |
Last Verified: | June 2017 |
Iron deficiency Iron fortification Iron encapsulation |
Anemia, Iron-Deficiency Anemia, Hypochromic Anemia Hematologic Diseases Iron Metabolism Disorders Metabolic Diseases Ascorbic Acid Fesoterodine Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |
Physiological Effects of Drugs Vitamins Micronutrients Nutrients Growth Substances Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Urological Agents |