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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
  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: Quadruple (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:


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 August 18, 2017