Nutrient Fortified Oat Drink

Iron Deficiency Anemia Clinical Trial

Official title:

The Effect of a Nutrient Fortified Oat Drink on Iron, Zinc, Vitamin A, and Vitamin C Status Among Filipino Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01418898
• Other study ID #: PEP 1011
• Status: Recruiting
• Phase: Phase 4
• First received: August 15, 2011
• Last updated: August 16, 2011
• Start date: August 2011
• Est. completion date: April 2012

Study information

• Verified date: August 2011
• Source: PepsiCo Global R&D
• Contact: Imelda Angeles-Agdeppa, PhD
• Phone: 011-63-2-8372071
• Email: imelda_agdeppa[@]yahoo.com
• Is FDA regulated: No
• Health authority: Philippines: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: April 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 7 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Iron Deficiency Anemia

Intervention

Other:
• Dietary Intervention
Nutrient fortified oat beverage

Locations

Country	Name	City	State
Philippines	FNRI	Taguig City

Sponsors (2)

Lead Sponsor	Collaborator
PepsiCo Global R&D	PepsiCo - Philippines

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Iron status: Change in hemoglobin and serum ferritin		Baseline and 4 months	No
Secondary	zinc, vitamin A and vitamin C status		Baseline and 4 months	No
Secondary	Weight, height, CRP and frequency of illness		Baseline and 4 months	No
Secondary	Dietary intake		Baseline and 4 months	No