Iron DeficiencyNCT01991626
Evaluation of the Effects of an Exogenous Phytase on Iron Absorption From LNS Added to Complementary Foods
A study testing micronutrient powder, micronutrient powder (containing FeSO4), phytase and Iron pyrophosphate (FePP) in people with Iron Deficiency, run by Swiss Federal Institute of Technology.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency
- What is being tested?
- micronutrient powder, micronutrient powder (containing FeSO4), phytase and Iron pyrophosphate (FePP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Evaluation of the Effects of an Exogenous Phytase on Iron Absorption From Lipid Nutrient Supplements Added to Complementary Foods
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.
- Conditions
- Iron Deficiency
- Being tested
- micronutrient powder, micronutrient powder (containing FeSO4), phytase, Iron pyrophosphate (FePP), Iron sulphate
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micronutrient powderDietary supplement
micronutrient powder (containing FeSO4), phytaseDietary supplement
Iron pyrophosphate (FePP)Dietary supplement
Iron sulphateDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| LNS | Other | Maize meal mixed with Lipid Nutrient Supplement (LNS) containing micronutrient powder Receives: Dietary Supplement: micronutrient powder |
| FePP-Emulsion mixed | Other | Fat emulsion mixed to the meal containing FePP Receives: Dietary Supplement: Iron pyrophosphate (FePP) |
| FeSO4-Mixed | Other | meals containing FeSO4 mixed with a fat emulsion Receives: Dietary Supplement: Iron sulphate |
| FePP-Emulsion before | Other | Fat emulsion taken before a meal containing FePP Receives: Dietary Supplement: Iron pyrophosphate (FePP) |
| FeSO4- Emulsion before | Other | Fat emulsion taken before a maize meal containing FeSO4 Receives: Dietary Supplement: Iron sulphate |
| LNS-Phytase | Other | Maize meal mixed with LNS containing micronutrient powder and phytase Receives: Dietary Supplement: micronutrient powder (containing FeSO4), phytase |
| phytase | Other | Maize meal containing micronutrient powder and phytase Receives: Dietary Supplement: micronutrient powder (containing FeSO4), phytase |
| MNP-control | Other | maize meal containing micronutrient powder (MNP) Receives: Dietary Supplement: micronutrient powder |
| FePP control | Other | Maize meal containing FePP Receives: Dietary Supplement: Iron pyrophosphate (FePP) |
| FeSO4 control | Other | Maize meal containing FeSO4 Receives: Dietary Supplement: Iron sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iron bio-availability from Oral Iron Supplements
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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startSep 2013
- Primary completionNov 2013
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG
- Responsible party
- Principal investigator, Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
- Investigators
- Michael B Zimmermann, Prof, Principal investigator, ETH Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01991626
- Sponsor's protocol ID
- Fe-LNS
- Status last verified
- Sep 2015
- First submitted
- 18 Nov 2013
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Monnard A, Moretti D, Zeder C, Steingotter A, Zimmermann MB. The effect of lipids, a lipid-rich ready-to-use therapeutic food, or a phytase on iron absorption from maize-based meals fortified with micronutrient powders. Am J Clin Nutr. 2017 Jun;105(6):1521-1527. doi: 10.3945/ajcn.116.142976. Epub 2017 May 3.
PubMed 28468891
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of an Exogenous Phytase on Iron Absorption From Lipid Nutrient Supplements Added to Complementary Foods
- ClinicalTrials.gov ID
- NCT01991626
- Acronym / sponsor ID
- Fe-LNS
- Conditions
- Iron Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG
- Study start
- Sep 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| LNS | Other | Dietary Supplement: micronutrient powderMaize meal mixed with Lipid Nutrient Supplement (LNS) containing micronutrient powder |
| FePP-Emulsion mixed | Other | Dietary Supplement: Iron pyrophosphate (FePP)Fat emulsion mixed to the meal containing FePP |
| FeSO4-Mixed | Other | Dietary Supplement: Iron sulphatemeals containing FeSO4 mixed with a fat emulsion |
| FePP-Emulsion before | Other | Dietary Supplement: Iron pyrophosphate (FePP)Fat emulsion taken before a meal containing FePP |
| FeSO4- Emulsion before | Other | Dietary Supplement: Iron sulphateFat emulsion taken before a maize meal containing FeSO4 |
| LNS-Phytase | Other | Dietary Supplement: micronutrient powder (containing FeSO4), phytaseMaize meal mixed with LNS containing micronutrient powder and phytase |
| phytase | Other | Dietary Supplement: micronutrient powder (containing FeSO4), phytaseMaize meal containing micronutrient powder and phytase |
| MNP-control | Other | Dietary Supplement: micronutrient powdermaize meal containing micronutrient powder (MNP) |
| FePP control | Other | Dietary Supplement: Iron pyrophosphate (FePP)Maize meal containing FePP |
| FeSO4 control | Other | Dietary Supplement: Iron sulphateMaize meal containing FeSO4 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| micronutrient powder | Dietary supplement | LNS, MNP-control |
| micronutrient powder (containing FeSO4), phytase | Dietary supplement | LNS-Phytase, phytase |
| Iron pyrophosphate (FePP) | Dietary supplement | FePP control, FePP-Emulsion before, FePP-Emulsion mixed |
| Iron sulphate | Dietary supplement | FeSO4 control, FeSO4- Emulsion before, FeSO4-Mixed |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
- Derived from this study: PubMed 28468891Monnard A, Moretti D, Zeder C, Steingotter A, Zimmermann MB. The effect of lipids, a lipid-rich ready-to-use therapeutic food, or a phytase on iron absorption from maize-based meals fortified with micronutrient powders. Am J Clin Nutr. 2017 Jun;105(6):1521-1527. doi: 10.3945/ajcn.116.142976. Epub 2017 May 3.
Related trials for Iron Deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Iron Absorption From a Nutritional Iron Supplement
Iron Absorption, Iron Deficiencies
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael B Zimmermann, Prof principal investigator
ETH Zürich
Questions about this trial
What is this clinical trial studying?
A study testing micronutrient powder, micronutrient powder (containing FeSO4), phytase and Iron pyrophosphate (FePP) in people with Iron Deficiency, run by Swiss Federal Institute of Technology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Iron bio-availability from Oral Iron Supplements (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01991626, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2015.