Iron Bioavailability of Fortified Oat Drink

PepsiCo

Status and phase: Completed; Phase 4

Conditions: Iron Absorption

Treatments: Other: Dietary Intervention (with Vit C then without Vit C); Other: Dietary Intervention (without Vit C followed by with Vit C)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01423162

PEP 1009

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 6 to 6 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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21 participants in 2 patient groups

Drink with Vit C then drink without Vit C

Experimental group

Description:

Fortified oat drink with vitamin C on day 1 followed by fortified oat drink without vitamin C on day 2

Treatment:

Other: Dietary Intervention (with Vit C then without Vit C)

Drink without Vit C then drink with Vit C

Experimental group

Description:

Fortified oat drink without vitamin C on day 1 followed by fortified oat drink with vitamin C on day 2

Treatment:

Other: Dietary Intervention (without Vit C followed by with Vit C)