NCT01423162

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2011

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 21, 2012

Completed
Last Updated

September 21, 2012

Status Verified

August 1, 2012

Enrollment Period

1 month

First QC Date

August 23, 2011

Results QC Date

August 22, 2012

Last Update Submit

August 22, 2012

Conditions

Iron Absorption

Keywords

Iron absorptionOatsfortified oat beverages

Outcome Measures

Primary Outcomes (1)

  • Percent Iron Absorption

    Percentage of iron available for absorption from fortified oat drink with and without added vitamin C

    14 days after administration

Study Arms (2)

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

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

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

Interventions

Dietary Intervention (with Vit C then without Vit C)OTHER

Fortified oat drink with vitamin C followed by fortified oat drink without vitamin C

Drink with Vit C then drink without Vit 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

Drink without Vit C then drink with Vit C

Eligibility Criteria

Age6 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Food and Nutrition Research Institute

City of Taguig, Philippines

Location

MeSH Terms

Interventions

Diet TherapyAscorbic Acid

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeuticsSugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Limitations and Caveats

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

Results Point of Contact

Title
Trinidad P. Trinidad
Organization
Food and Nutrition Research Institute
trinidadtp@yahoo.com.ph
6328372071

Study Officials

  • Trinidad P Trinidad, PhD

    FNRI

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2011

First Posted

August 25, 2011

Study Start

August 1, 2011

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

September 21, 2012

Results First Posted

September 21, 2012

Record last verified: 2012-08

Locations

PH(1)