Phase 4 N=20 Randomized Quadruple-blind Basic Science

Iron Bioavailability of Fortified Oat Drink

Iron Absorption

Bottom Line

View on ClinicalTrials.gov: NCT01423162 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Sep 2012

Primary outcome: Primary: Percent Iron Absorption — 7.14; 5.65 percentage of Iron absorbed

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Dietary Intervention (with Vit C then without Vit C) (Other); Dietary Intervention (without Vit C followed by with Vit C) (Other)
Age: Pediatric · 6+ yrs
Sex: All
Sponsor: PepsiCo Global R&D
Primary completion: Sep 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Iron Absorption	7.14; 5.65	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01423162). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.