Nutrient Fortified Oat Drink

Phase 4

• Conditions: Iron Deficiency Anemia

• Registration Number: NCT01418898
• Lead Sponsor: PepsiCo Global R&D

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-08
• Study Start: 2011-08
• Study First Submitted: 2011-08-15
• Study First Submitted QC: 2011-08-16
• Last Update Submitted: 2011-08-16
• Study First Posted: 2011-08-17
• Last Update Posted: 2011-08-17
• Primary Completion: 2011-12
• Study Completion: 2012-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Iron status: Change in hemoglobin and serum ferritin	Baseline and 4 months

Secondary Outcome Measures

Name	Time	Method
zinc, vitamin A and vitamin C status	Baseline and 4 months
Weight, height, CRP and frequency of illness	Baseline and 4 months
Dietary intake	Baseline and 4 months

Trial Locations

Locations (1)

FNRI; 🇵🇭 Taguig City, Philippines

FNRI

🇵🇭Taguig City, Philippines

Angeles-Agdeppa

Contact

011-63-2-8372071

Imelda Angeles-Agdeppa, PhD

Principal Investigator