We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov 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
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Iron Deficiency Anemia Other: Dietary Intervention Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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
Study Start Date : August 2011
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron Vitamin A
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Nutrient Fortified Beverage Other: Dietary Intervention
Nutrient fortified oat beverage
Placebo Comparator: Control Other: Dietary Intervention
Nutrient fortified oat beverage


Outcome Measures

Primary Outcome Measures :
  1. Iron status: Change in hemoglobin and serum ferritin [ Time Frame: Baseline and 4 months ]

Secondary Outcome Measures :
  1. zinc, vitamin A and vitamin C status [ Time Frame: Baseline and 4 months ]
  2. Weight, height, CRP and frequency of illness [ Time Frame: Baseline and 4 months ]
  3. Dietary intake [ Time Frame: Baseline and 4 months ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: August 17, 2011    Key Record Dates
Last Update Posted: August 17, 2011
Last Verified: August 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