Nutrient Fortified Oat Drink

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified August 2011 by PepsiCo Global R&D.
Recruitment status was: Recruiting

Sponsor:

Collaborator:

PepsiCo - Philippines

Information provided by:

PepsiCo Global R&D

ClinicalTrials.gov Identifier:

NCT01418898

First received: August 15, 2011

Last updated: August 16, 2011

Last verified: August 2011

History of Changes

Purpose

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.

Condition	Intervention	Phase
Iron Deficiency Anemia	Other: Dietary Intervention	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	The Effect of a Nutrient Fortified Oat Drink on Iron, Zinc, Vitamin A, and Vitamin C Status Among Filipino Children

Resource links provided by NLM:

MedlinePlus related topics: Iron Vitamin A

U.S. FDA Resources

Further study details as provided by PepsiCo Global R&D:

Primary Outcome Measures:

Iron status: Change in hemoglobin and serum ferritin [ Time Frame: Baseline and 4 months ]

Secondary Outcome Measures:

zinc, vitamin A and vitamin C status [ Time Frame: Baseline and 4 months ]
Weight, height, CRP and frequency of illness [ Time Frame: Baseline and 4 months ]
Dietary intake [ Time Frame: Baseline and 4 months ]


Estimated Enrollment:	80
Study Start Date:	August 2011
Estimated Study Completion Date:	April 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Nutrient Fortified Beverage	Other: Dietary Intervention Nutrient fortified oat beverage
Placebo Comparator: Control	Other: Dietary Intervention Nutrient fortified oat beverage

Eligibility


Ages Eligible for Study:	5 Years to 7 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01418898

Contacts


Contact: Imelda Angeles-Agdeppa, PhD	011-63-2-8372071 ext 2280	imelda_agdeppa@yahoo.com
Contact: Ma. Lilibeth P Dasco, RND	011-63-2-8372071 ext 2280	mlpd@fnri.dost.gov.ph

Locations


Philippines
FNRI	Recruiting
Taguig City, Philippines
Contact: Angeles-Agdeppa 011-63-2-8372071 ext 2280
Principal Investigator: Imelda Angeles-Agdeppa, PhD

Sponsors and Collaborators

PepsiCo Global R&D

PepsiCo - Philippines

Investigators


Principal Investigator:	Imelda Angeles-Agdeppa, PhD	FNRI

More Information


Responsible Party:	Imelda Angeles-Agdeppa, Ph.D, Food and Nutrition Research Institute Department of Science and Technology
ClinicalTrials.gov Identifier:	NCT01418898 History of Changes
Other Study ID Numbers:	PEP 1011
Study First Received:	August 15, 2011
Last Updated:	August 16, 2011

Keywords provided by PepsiCo Global R&D:


Iron deficiency anemia iron zinc	vitamin A vitamin C oats

Additional relevant MeSH terms:


Anemia, Iron-Deficiency Anemia, Hypochromic Anemia Hematologic Diseases Iron Metabolism Disorders Metabolic Diseases	Vitamins Vitamin A Micronutrients Growth Substances Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 28, 2017

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