Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

August 15, 2011
August 16, 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 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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 ]
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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
80
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
Both
5 Years to 7 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Philippines
 
NCT01418898
PEP 1011
No
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