Iron Deficiency AnemiaPhase 4NCT01418898
Nutrient Fortified Oat Drink
A Phase 4 study testing Dietary Intervention in people with Iron Deficiency Anemia, run by PepsiCo Global R&D at 1 site in Philippines.
Trial summary
This study will follow a randomized, double-blind, placebo-controlled, parallel-group design to test if an oat beverage fortified with iron, zinc vitamin A and vitamin C will improve nutrient status and iron deficiency in young children compared to an unfortified control beverage. Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Dietary Intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 sitePhilippines
- Study dates
- Aug 2011to Apr 2012
- Phase
- Phase 4
- 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 5 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 5-7 years old
- Children with parental consent
- Not suffering from diarrhea, respiratory infections and fever at time of interview and for the past two weeks
- No history of blood disorder or malaria
- Had not participated in any feeding program for the past 4 months
- Children with Hb > 70 g/L to <120 g/L (WHO/UNICEF/UNU, 1998)
- CRP <10 mg/L
Who cannot join
- All children aged < 5 years old and > 7 years old
- Without parental consent
- Undergoing treatment for any chronic ailment, diagnosed as suffering from any sort of illness e.g. fever, diarrhea, stomach ache, cough and colds at the time of examination or during the past two weeks.
- Reported current or history of blood abnormalities/hemoglobinopathies
- Children with all normal Hb levels or very low Hb < 70 g/L
- CRP >10mg/L
Trial locations and contacts
1 site in 1 country.
Philippines1 site, 1 recruiting
- Recruiting
FNRI
City of Taguig
Angeles-Agdeppa, 011-63-2-8372071 ext. 2280
Imelda Angeles-Agdeppa, PhD
About this study
Official title: The Effect of a Nutrient Fortified Oat Drink on Iron, Zinc, Vitamin A, and Vitamin C Status Among Filipino Children
This study will follow a randomized, double-blind, placebo-controlled, parallel-group design to test if an oat beverage fortified with iron, zinc vitamin A and vitamin C will improve nutrient status and iron deficiency in young children compared to an unfortified control beverage.
- Conditions
- Iron Deficiency Anemia
- Being tested
- Dietary Intervention
- Keywords
- Iron deficiency anemia, iron, zinc, vitamin A, vitamin C, oats
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary InterventionOther
Nutrient fortified oat beverage
| Study group | Role | What they receive |
|---|---|---|
| Nutrient Fortified Beverage | Experimental | Not described Receives: Other: Dietary Intervention |
| Control | Placebo comparator | Not described Receives: Other: Dietary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iron status: Change in hemoglobin and serum ferritin
Measured: Baseline and 4 months
Secondary outcomes (3)
zinc, vitamin A and vitamin C status
Measured: Baseline and 4 months
Weight, height, CRP and frequency of illness
Measured: Baseline and 4 months
Dietary intake
Measured: Baseline and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2011 (estimated)
- Study completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PepsiCo - Philippines
- Investigators
- Imelda Angeles-Agdeppa, PhD, Principal investigator, FNRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418898
- Sponsor's protocol ID
- PEP 1011
- Status last verified
- Aug 2011
- First submitted
- 15 Aug 2011
- Last updated
- 17 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Nutrient Fortified Oat Drink on Iron, Zinc, Vitamin A, and Vitamin C Status Among Filipino Children
- ClinicalTrials.gov ID
- NCT01418898
- Acronym / sponsor ID
- PEP 1011
- Conditions
- Iron Deficiency Anemia
- Keywords
- Iron deficiency anemia, iron, zinc, vitamin A, vitamin C, oats
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Collaborators
- PepsiCo - Philippines
- Study start
- Aug 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 17 Aug 2011 (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.
This study will follow a randomized, double-blind, placebo-controlled, parallel-group design to test if an oat beverage fortified with iron, zinc vitamin A and vitamin C will improve nutrient status and iron deficiency in young children compared to an unfortified control beverage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrient Fortified Beverage | Experimental | Other: Dietary Intervention |
| Control | Placebo comparator | Other: Dietary Intervention |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 5-7 years old
- Children with parental consent
- Not suffering from diarrhea, respiratory infections and fever at time of interview and for the past two weeks
- No history of blood disorder or malaria
- Had not participated in any feeding program for the past 4 months
Key exclusion criteria (6 listed)
- All children aged < 5 years old and > 7 years old
- Without parental consent
- Undergoing treatment for any chronic ailment, diagnosed as suffering from any sort of illness e.g. fever, diarrhea, stomach ache, cough and colds at the time of examination or during the past two weeks.
- Reported current or history of blood abnormalities/hemoglobinopathies
- Children with all normal Hb levels or very low Hb < 70 g/L
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 InterventionNutrient fortified oat beverage | Other | Control, Nutrient Fortified Beverage |
Primary outcome
Iron status: Change in hemoglobin and serum ferritin
Time frame: Baseline and 4 months
3 secondary outcomes
zinc, vitamin A and vitamin C status
Time frame: Baseline and 4 months
Weight, height, CRP and frequency of illness
Time frame: Baseline and 4 months
Dietary intake
Time frame: Baseline and 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2011.
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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.
Imelda Angeles-Agdeppa, 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?
A Phase 4 study testing Dietary Intervention in people with Iron Deficiency Anemia, run by PepsiCo Global R&D at 1 site in Philippines.
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 7 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: status not confirmed, as of the sponsor's last update on 17 Aug 2011. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imelda Angeles-Agdeppa, PhD (011-63-2-8372071 ext. 2280, imelda_agdeppa@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Iron status: Change in hemoglobin and serum ferritin (time frame: Baseline and 4 months). 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 17 Aug 2011.