Iron Absorption
Conditions
Keywords
Iron absorption, Oats, fortified oat beverages
Brief 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.
Interventions
OTHERDietary Intervention (with Vit C then without Vit C)
Fortified oat drink with vitamin C followed by fortified oat drink without vitamin C
OTHERDietary Intervention (without Vit C followed by with Vit C)
Fortified oat drink without vitamin C followed by fortified oat drink with vitamin C
Sponsors
Food and Nutrition Research Institute, Philippines
PepsiCo Global R&D
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 6 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Iron Absorption | 14 days after administration | Percentage of iron available for absorption from fortified oat drink with and without added vitamin C |
Countries
Philippines
Participant flow
Recruitment details
Recruitment took place in August 2011
Pre-assignment details
One subject was excluded prior to group assignment due to illness
Participants by arm
| Arm | Count |
|---|---|
| Drink With Vit C Then Drink Without Vit C Dietary Intervention (with Vitamin C): Fortified oat drink with vitamin C followed by fortified oat drink without Vit C | 11 |
| Drink Without Vit C Then Drink With Vit C Dietary Intervention (without Vitamin C): Fortified oat drink without vitamin C followed by fortified oat drink with vitamin C | 9 |
| Total | 20 |
Baseline characteristics
| Characteristic | Drink Without Vit C Then Drink With Vit C | Drink With Vit C Then Drink Without Vit C | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 9 Participants | 11 Participants | 20 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized years | 6.4 years | 6.3 years | 6.3 years |
| Region of Enrollment Philippines | 9 participants | 11 participants | 20 participants |
| Sex: Female, Male Female | 5 Participants | 7 Participants | 12 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Percent Iron Absorption
Percentage of iron available for absorption from fortified oat drink with and without added vitamin C
Time frame: 14 days after administration
Population: Per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fortified Oat Drink With Vitamin C | Percent Iron Absorption | 7.14 percentage of Iron absorbed | Standard Error 0.9 |
| Fortified Oat Drink Without Vitamin C | Percent Iron Absorption | 5.65 percentage of Iron absorbed | Standard Error 0.54 |