Nutrient Fortified Oat Drink
Information source: PepsiCo Global R&D
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Iron Deficiency Anemia
Intervention: Dietary Intervention (Other)
Phase: Phase 4
Status: Recruiting
Sponsored by: PepsiCo Global R&D Official(s) and/or principal investigator(s): Imelda Angeles-Agdeppa, PhD, Principal Investigator, Affiliation: FNRI
Overall contact: Imelda Angeles-Agdeppa, PhD, Phone: 011-63-2-8372071, Ext: 2280, Email: imelda_agdeppa@yahoo.com
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.
Clinical Details
Official title: The Effect of a Nutrient Fortified Oat Drink on Iron, Zinc, Vitamin A, and Vitamin C Status Among Filipino Children
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Iron status: Change in hemoglobin and serum ferritin
Secondary outcome: zinc, vitamin A and vitamin C statusWeight, height, CRP and frequency of illness Dietary intake
Eligibility
Minimum age: 5 Years.
Maximum age: 7 Years.
Gender(s): Both.
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
Locations and Contacts
Imelda Angeles-Agdeppa, PhD, Phone: 011-63-2-8372071, Ext: 2280, Email: imelda_agdeppa@yahoo.com
FNRI, Taguig City, Philippines; Recruiting Angeles-Agdeppa, Phone: 011-63-2-8372071, Ext: 2280 Imelda Angeles-Agdeppa, PhD, Principal Investigator
Additional Information
Starting date: August 2011
Last updated: August 16, 2011
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