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Nutrient Fortified Oat Drink

This study is currently recruiting participants.
Verified August 2011 by PepsiCo Global R&D
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • zinc, vitamin A and vitamin C status [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]
  • Weight, height, CRP and frequency of illness [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]
  • Dietary intake [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
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

No publications provided

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
Health Authority: Philippines: Ethics Committee

Keywords provided by PepsiCo Global R&D:
Iron deficiency anemia
iron
zinc
 vitamin A
vitamin C
oats

Additional relevant MeSH terms:
Anemia
Deficiency Diseases
Anemia, Iron-Deficiency
Hematologic Diseases
Malnutrition
Nutrition Disorders
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Ascorbic Acid
 Vitamin A
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 19, 2013