BioavailabilityNCT01506648
Assessment of Zinc Absorption From a Phytic Acid Rich Complementary Food
An observational study of Bioavailability, run by Swiss Federal Institute of Technology at 1 site in Burkina Faso.
Trial summary
Assessment of zinc absorption from a phytic acid rich complementary food, consumed by young children immediately after the addition of the enzyme phytase. A randomized single blind study Read more about this study
- Who is it for?
- Ages 12 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability
- How many people
- 40 participants
- Where
- 1 siteBurkina Faso
- Study dates
- Jan 2011to Oct 2012
- Phase
- Observational
- 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 12 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Study not related to a disease. Nutrition study without drug drug administration. Assessment of zinc absorption from a phytic acid rich complementary food, consumed by young children immediately after the addition of the enzyme phytase. A randomized single blind study
Who may be able to join
- 12-24 month old
- Male of female
- Height and weight between -2.0 SD and +2.0 SD with respect to WHO child growth standards.
- No mineral and vitamin supplements 2 weeks prior to the study and during the whole duration of the study
Who cannot join
- Body temperature ≥ 37.5°C
- Hemoglobin ≤ 7g/dL
- Positive RDT test
- Any metabolic, gastrointestinal or chronic disease (according to the statement of the subject's parent) known chronic diseases at the gastrointestinal tract)
- Long term mediation (that may affect zinc metabolism) during the whole study to interact with zinc metabolism (such as kidney diseases or
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Zinc Absorption From a Phytic Acid Rich Complementary Food, Consumed by Young Children Immediately After the Addition of the Enzyme Phytase. A Randomized Single Blind Study
Assessment of zinc absorption from a phytic acid rich complementary food, consumed by young children immediately after the addition of the enzyme phytase. A randomized single blind study
- Conditions
- Bioavailability
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional absorption of zinc
Fractional absorption of zinc is estimated by using the double isotope tracer ratio technique by administering 67Zn as oral and 70Zn as intravenous stable isotopes.The urinary enrichment with both isotopes is measured in a spot urine sample by inductively coupled plasma mass spectrometry.
Measured: 33 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study startJan 2011
- Primary completionApr 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioavailabilityStudies 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
- Observational
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01506648
- Sponsor's protocol ID
- INSTAPA-FP7-211484
- Status last verified
- Nov 2016
- First submitted
- 9 Jan 2012
- Last updated
- 28 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Zinc Absorption From a Phytic Acid Rich Complementary Food, Consumed by Young Children Immediately After the Addition of the Enzyme Phytase. A Randomized Single Blind Study
- ClinicalTrials.gov ID
- NCT01506648
- Acronym / sponsor ID
- INSTAPA-FP7-211484
- Conditions
- Bioavailability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 10 Jan 2012 (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.
Assessment of zinc absorption from a phytic acid rich complementary food, consumed by young children immediately after the addition of the enzyme phytase. A randomized single blind study
Study design
Who may qualify
- Ages
- 12 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Study not related to a disease. Nutrition study without drug drug administration. Assessment of zinc absorption from a phytic acid rich complementary food, consumed by young children immediately after the addition of the enzyme phytase. A randomized single blind study
Key inclusion criteria (4 listed)
- 12-24 month old
- Male of female
- Height and weight between -2.0 SD and +2.0 SD with respect to WHO child growth standards.
- No mineral and vitamin supplements 2 weeks prior to the study and during the whole duration of the study
Key exclusion criteria (5 listed)
- Body temperature ≥ 37.5°C
- Hemoglobin ≤ 7g/dL
- Positive RDT test
- Any metabolic, gastrointestinal or chronic disease (according to the statement of the subject's parent) known chronic diseases at the gastrointestinal tract)
- Long term mediation (that may affect zinc metabolism) during the whole study to interact with zinc metabolism (such as kidney diseases or
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fractional absorption of zinc
Time frame: 33 days
Fractional absorption of zinc is estimated by using the double isotope tracer ratio technique by administering 67Zn as oral and 70Zn as intravenous stable isotopes.The urinary enrichment with both isotopes is measured in a spot urine sample by inductively coupled plasma 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 28 Nov 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bioavailability, run by Swiss Federal Institute of Technology at 1 site in Burkina Faso.
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 4 inclusion and 5 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 28 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Burkina Faso. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Fractional absorption of zinc (time frame: 33 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Nov 2016.