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Nutrient Fortified Oat Drink

Primary Purpose

Iron Deficiency Anemia

Status
Unknown status
Phase
Phase 4
Locations
Philippines
Study Type
Interventional
Intervention
Dietary Intervention
Sponsored by
PepsiCo Global R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iron Deficiency Anemia focused on measuring Iron deficiency anemia, iron, zinc, vitamin A, vitamin C, oats

Eligibility Criteria

5 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • FNRIRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nutrient Fortified Beverage

Control

Arm Description

Outcomes

Primary Outcome Measures

Iron status: Change in hemoglobin and serum ferritin

Secondary Outcome Measures

zinc, vitamin A and vitamin C status
Weight, height, CRP and frequency of illness
Dietary intake

Full Information

First Posted
August 15, 2011
Last Updated
August 16, 2011
Sponsor
PepsiCo Global R&D
Collaborators
PepsiCo - Philippines
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1. Study Identification

Unique Protocol Identification Number
NCT01418898
Brief Title
Nutrient Fortified Oat Drink
Official Title
The Effect of a Nutrient Fortified Oat Drink on Iron, Zinc, Vitamin A, and Vitamin C Status Among Filipino Children
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
April 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
PepsiCo Global R&D
Collaborators
PepsiCo - Philippines

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia
Keywords
Iron deficiency anemia, iron, zinc, vitamin A, vitamin C, oats

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nutrient Fortified Beverage
Arm Type
Experimental
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Dietary Intervention
Intervention Description
Nutrient fortified oat beverage
Primary Outcome Measure Information:
Title
Iron status: Change in hemoglobin and serum ferritin
Time Frame
Baseline and 4 months
Secondary Outcome Measure Information:
Title
zinc, vitamin A and vitamin C status
Time Frame
Baseline and 4 months
Title
Weight, height, CRP and frequency of illness
Time Frame
Baseline and 4 months
Title
Dietary intake
Time Frame
Baseline and 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imelda Angeles-Agdeppa, PhD
Phone
011-63-2-8372071
Ext
2280
Email
imelda_agdeppa@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ma. Lilibeth P Dasco, RND
Phone
011-63-2-8372071
Ext
2280
Email
mlpd@fnri.dost.gov.ph
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Imelda Angeles-Agdeppa, PhD
Organizational Affiliation
FNRI
Official's Role
Principal Investigator
Facility Information:
Facility Name
FNRI
City
Taguig City
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angeles-Agdeppa
Phone
011-63-2-8372071
Ext
2280
First Name & Middle Initial & Last Name & Degree
Imelda Angeles-Agdeppa, PhD

12. IPD Sharing Statement

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Nutrient Fortified Oat Drink

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