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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 status

Weight, 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

Page last updated: August 20, 2015

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