Evaluation of the Effects of an Exogenous Phytase on Iron Absorption From LNS Added to Complementary Foods
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ClinicalTrials.gov Identifier: NCT01991626 |
Recruitment Status :
Completed
First Posted : November 25, 2013
Last Update Posted : September 23, 2015
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Previous studies on iron absorption have focused on the effects on the addition of iron absorption enhancers like ascorbic acid and EDTA to a meal and more recently the enzymatic phytic acid removal through phytase. The investigators want here to investigate the effects of fat on iron absorption with and without the addition of exogenous phytase as a potential iron absorption enhancer in lipid nutrient supplements (LNS) products compared to micronutrient powder(MNP) products.
Furthermore the investigators will evaluate the effects of Lipids- on iron absorption to induce the ileal brake by ingestion of a fat emulsion prior to a meal. Increasing the caloric density of a meal by increasing its fat content might enhance iron absorption by delaying gastric emptying, gastric acid secretion and increasing Fe stomach residence time.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Iron Deficiency | Dietary Supplement: micronutrient powder Dietary Supplement: micronutrient powder (containing FeSO4), phytase Dietary Supplement: Iron pyrophosphate (FePP) Dietary Supplement: Iron sulphate | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 47 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Basic Science |
Official Title: | Evaluation of the Effects of an Exogenous Phytase on Iron Absorption From Lipid Nutrient Supplements Added to Complementary Foods |
Study Start Date : | September 2013 |
Actual Primary Completion Date : | November 2013 |
Actual Study Completion Date : | August 2014 |

Arm | Intervention/treatment |
---|---|
LNS
Maize meal mixed with Lipid Nutrient Supplement (LNS) containing micronutrient powder
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Dietary Supplement: micronutrient powder |
FePP-Emulsion mixed
Fat emulsion mixed to the meal containing FePP
|
Dietary Supplement: Iron pyrophosphate (FePP) |
FeSO4-Mixed
meals containing FeSO4 mixed with a fat emulsion
|
Dietary Supplement: Iron sulphate |
FePP-Emulsion before
Fat emulsion taken before a meal containing FePP
|
Dietary Supplement: Iron pyrophosphate (FePP) |
FeSO4- Emulsion before
Fat emulsion taken before a maize meal containing FeSO4
|
Dietary Supplement: Iron sulphate |
LNS-Phytase
Maize meal mixed with LNS containing micronutrient powder and phytase
|
Dietary Supplement: micronutrient powder (containing FeSO4), phytase |
phytase
Maize meal containing micronutrient powder and phytase
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Dietary Supplement: micronutrient powder (containing FeSO4), phytase |
MNP-control
maize meal containing micronutrient powder (MNP)
|
Dietary Supplement: micronutrient powder |
FePP control
Maize meal containing FePP
|
Dietary Supplement: Iron pyrophosphate (FePP) |
FeSO4 control
Maize meal containing FeSO4
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Dietary Supplement: Iron sulphate |
- Iron bio-availability from Oral Iron Supplements [ Time Frame: 14 days ]Iron bioavailability will be assessed with stable isotopic labels. The shift in the isotopic ratio in human whole blood 14 days after administration will be measured with mass spectrometry.

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Reproductive age females 18-45 years
- Normal body mass index (17.5-25 kg/m2)
- No intake of mineral/vitamin supplements 2 weeks before and during the study
- No metabolic or gastrointestinal disorders
- No food allergies or other chronic disorders or eating disorders assessed by self-report
- Having received full oral and written information about the aims and procedures of the study
- Willing to comply with the study procedure
- Having provided oral and written informed consent
Exclusion Criteria:
- Regular intake of medication (except oral contraceptives)
- Blood donation or significant blood loss (accident, surgery) over the past 4 months
- Currently participating in another clinical trial or having participated in another clinical trial during the last 30 days prior to the beginning of this study
- Former participation in a study involving administration of iron stable isotopes
- Subject who cannot be expected to comply with study protocol
- Pregnancy or lactation

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): NCT01991626
Principal Investigator: | Michael B Zimmermann, Prof | ETH Zürich |
Responsible Party: | Prof. Michael B. Zimmermann, Prof, Swiss Federal Institute of Technology |
ClinicalTrials.gov Identifier: | NCT01991626 |
Other Study ID Numbers: |
Fe-LNS |
First Posted: | November 25, 2013 Key Record Dates |
Last Update Posted: | September 23, 2015 |
Last Verified: | September 2015 |
Anemia, Iron-Deficiency Anemia, Hypochromic Anemia Hematologic Diseases Iron Metabolism Disorders |
Metabolic Diseases Iron Trace Elements Micronutrients Physiological Effects of Drugs |