Nutrient Fortified Oat Drink

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01418898
Recruitment Status : Unknown
Verified August 2011 by PepsiCo Global R&D.
Recruitment status was:  Recruiting
First Posted : August 17, 2011
Last Update Posted : August 17, 2011
PepsiCo - Philippines
Information provided by:
PepsiCo Global R&D

August 15, 2011
August 17, 2011
August 17, 2011
August 2011
December 2011   (Final data collection date for primary outcome measure)
Iron status: Change in hemoglobin and serum ferritin [ Time Frame: Baseline and 4 months ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
Nutrient Fortified Oat Drink
The Effect of a Nutrient Fortified Oat Drink on Iron, Zinc, Vitamin A, and Vitamin C Status Among Filipino Children
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.
Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Iron Deficiency Anemia
Other: Dietary Intervention
Nutrient fortified oat beverage
  • Experimental: Nutrient Fortified Beverage
    Intervention: Other: Dietary Intervention
  • Placebo Comparator: Control
    Intervention: Other: Dietary Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
April 2012
December 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
5 Years to 7 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
PEP 1011
Not Provided
Not Provided
Imelda Angeles-Agdeppa, Ph.D, Food and Nutrition Research Institute Department of Science and Technology
PepsiCo Global R&D
PepsiCo - Philippines
Principal Investigator: Imelda Angeles-Agdeppa, PhD FNRI
PepsiCo Global R&D
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP