Iron AbsorptionPhase 4NCT01423162

Iron Bioavailability of Fortified Oat Drink

A Phase 4 study testing Dietary Intervention (with Vit C then without Vit C) and Dietary Intervention (without Vit C followed by with Vit C) in people with Iron Absorption, run by PepsiCo Global R&D at 1 site in Philippines.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 6 to 6 yearsHealthy volunteers can take part
Conditions the study is for: Iron Absorption
What is being tested?: Dietary Intervention (with Vit C then without Vit C) and Dietary Intervention (without Vit C followed by with Vit C)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 sitePhilippines
Study dates: Aug 2011to Sep 2011
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 6 to 6 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

6 year old children (inclusive)
Normal BMI for age (WHO standard: 15.3-15.5 kg)
Apparently healthy, no metabolic or gastrointestinal disorder; non-anemic (Hemoglobin values not less than 11.5 mg/dL -WHO cut-off for respective age)
No medication or vitamin/mineral supplement will be consumed during the study; intake of vitamin/mineral supplement will be discontinued 2 weeks before the start of the study
Parents demonstrate an understanding of the given information and ability to comply with the study procedure
Obtained parental or legal representative's informed consent

Who cannot join

Known gastrointestinal or metabolic disorder or experiencing blood losses over the past 6 months;
Children taking medication
Children who are anemic (Hemoglobin values less than 11.5 mg/dL - WHO cut-off value for this age)
Currently participating or having participated in another clinical trial during the past 3 months prior to the beginning of the study

Trial locations and contacts

1 site in 1 country.

Philippines1 site

Food and Nutrition Research Institute
City of Taguig

Other trials in Philippines

About this study

Official title: Iron Bioavailability Study Of Fortified Oat Drink

This study will follow a double blinded randomized controlled study design to enroll 20 apparently healthy 6 year old children. The children will be fed with two different nutrient fortified oat drinks labeled with stable isotopes of iron (Fe-57 or Fe-58 as NaFeEDTA). Fourteen days after consumption of meals on Day 2, blood will be drawn from the children for stable isotope measurements and iron absorption will be calculated.

Conditions: Iron Absorption
Being tested: Dietary Intervention (with Vit C then without Vit C), Dietary Intervention (without Vit C followed by with Vit C)
Keywords: Iron absorption, Oats, fortified oat beverages

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dietary Intervention (with Vit C then without Vit C)Other
Fortified oat drink with vitamin C followed by fortified oat drink without vitamin C
Dietary Intervention (without Vit C followed by with Vit C)Other
Fortified oat drink without vitamin C followed by fortified oat drink with vitamin C

Study groups in NCT01423162
Study group	Role	What they receive
Drink with Vit C then drink without Vit C	Experimental	Fortified oat drink with vitamin C on day 1 followed by fortified oat drink without vitamin C on day 2 Receives: Other: Dietary Intervention (with Vit C then without Vit C)
Drink without Vit C then drink with Vit C	Experimental	Fortified oat drink without vitamin C on day 1 followed by fortified oat drink with vitamin C on day 2 Receives: Other: Dietary Intervention (without Vit C followed by with Vit C)

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Iron Absorption
Percentage of iron available for absorption from fortified oat drink with and without added vitamin C
Measured: 14 days after administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2011Sep 2011

First posted25 Aug 2011 (estimated)
Study startAug 2011
Primary completionSep 2011
Study completionSep 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Iron AbsorptionStudies 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 4
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01423162
Sponsor's protocol ID: PEP 1009
Status last verified: Aug 2012
First submitted: 23 Aug 2011
Last updated: 21 Sep 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Iron Absorption From a Nutritional Iron Supplement
Iron Absorption, Iron Deficiencies
Active, not recruiting
Iron Absorption From IFA and MMS Supplements in Kenyan Women During the Second Trimester of Pregnancy
Pregnancy
Active, not recruiting
Absorption of Iron From Stabilized Lactoferrin: A Study in Women With Iron Deficiency
Iron Deficiency (Without Anemia)
Active, not recruitingObservational study
Ethnic Differences in Iron Absorption (FeGenes)
Anemia, Iron Deficiency, Iron Overload
Active, not recruitingObservational study
Heme and Non-heme Iron Intakes, Gut Microbiota, and Influence on Host Iron Absorption
Anemia, Iron Deficiency, Iron Overload

All Iron Absorption trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Iron Bioavailability Study Of Fortified Oat Drink
ClinicalTrials.gov ID: NCT01423162
Acronym / sponsor ID: PEP 1009
Conditions: Iron Absorption
Keywords: Iron absorption, Oats, fortified oat beverages
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: PepsiCo Global R&DIndustry (pharma, biotech, devices)
Collaborators: Food and Nutrition Research Institute, Philippines
Study start: Aug 2011
Primary completion: Sep 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 25 Aug 2011 (estimated)
Results: Posted 21 Sep 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Drink with Vit C then drink without Vit C	Experimental	Other: Dietary Intervention (with Vit C then without Vit C)Fortified oat drink with vitamin C on day 1 followed by fortified oat drink without vitamin C on day 2
Drink without Vit C then drink with Vit C	Experimental	Other: Dietary Intervention (without Vit C followed by with Vit C)Fortified oat drink without vitamin C on day 1 followed by fortified oat drink with vitamin C on day 2

Who may qualify

Ages: 6 to 6 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (6 listed)

6 year old children (inclusive)
Normal BMI for age (WHO standard: 15.3-15.5 kg)
Apparently healthy, no metabolic or gastrointestinal disorder; non-anemic (Hemoglobin values not less than 11.5 mg/dL -WHO cut-off for respective age)
No medication or vitamin/mineral supplement will be consumed during the study; intake of vitamin/mineral supplement will be discontinued 2 weeks before the start of the study
Parents demonstrate an understanding of the given information and ability to comply with the study procedure

Key exclusion criteria (4 listed)

Known gastrointestinal or metabolic disorder or experiencing blood losses over the past 6 months;
Children taking medication
Children who are anemic (Hemoglobin values less than 11.5 mg/dL - WHO cut-off value for this age)
Currently participating or having participated in another clinical trial during the past 3 months prior to the beginning of the study

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
Dietary Intervention (with Vit C then without Vit C)Fortified oat drink with vitamin C followed by fortified oat drink without vitamin C	Other	Drink with Vit C then drink without Vit C
Dietary Intervention (without Vit C followed by with Vit C)Fortified oat drink without vitamin C followed by fortified oat drink with vitamin C	Other	Drink without Vit C then drink with Vit C

Primary outcome

Percent Iron Absorption
Time frame: 14 days after administration
Percentage of iron available for absorption from fortified oat drink with and without added vitamin C

Results and safety

Results posted to the registry on 21 Sep 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Drink With Vit C Then Drink Without Vit C	11	11
Drink Without Vitamin C Then Drink With Vit C	9	9

Primary outcome: Percent Iron Absorption

Time frame: 14 days after administration. Mean (Standard Error). Unit: percentage of Iron absorbed

Measure	Fortified Oat Drink With Vitamin C n = 19	Fortified Oat Drink Without Vitamin C n = 19
Value	7.14 (0.90)	5.65 (0.54)

Population analysed: Per protocol

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Drink With Vit C Then Drink Without Vit C	0 of 0	0 of 0	Not reported
Drink Without Vitamin C Then Drink With Vit C	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): One of the isotopes was not detected in blood sample of 1 participant, therefore data from this participant was excluded from final per protocol analysis

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Iron Absorption

Recruiting
Iron Absorption From a Nutritional Iron Supplement
Iron Absorption, Iron Deficiencies
Active, not recruiting
Iron Absorption From IFA and MMS Supplements in Kenyan Women During the Second Trimester of Pregnancy
Pregnancy
Active, not recruiting
Absorption of Iron From Stabilized Lactoferrin: A Study in Women With Iron Deficiency
Iron Deficiency (Without Anemia)
Active, not recruitingObservational study
Ethnic Differences in Iron Absorption (FeGenes)
Anemia, Iron Deficiency, Iron Overload
Active, not recruitingObservational study
Heme and Non-heme Iron Intakes, Gut Microbiota, and Influence on Host Iron Absorption
Anemia, Iron Deficiency, Iron Overload

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.

Trinidad P Trinidad, PhD principal investigator

FNRI

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 4 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 21 Sep 2012. 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 Philippines. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percent Iron Absorption (time frame: 14 days after administration). 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 NCT01423162.

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 21 Sep 2012.