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Nutrient Fortified Oat Drink

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01418898
Enrollment
80
Registered
2011-08-17
Start date
2011-08-31
Completion date
2012-04-30
Last updated
2011-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiency Anemia

Keywords

Iron deficiency anemia, iron, zinc, vitamin A, vitamin C, oats

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.

Interventions

OTHERDietary Intervention

Nutrient fortified oat beverage

Sponsors

PepsiCo - Philippines
CollaboratorUNKNOWN
PepsiCo Global R&D
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
5 Years to 7 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Iron status: Change in hemoglobin and serum ferritinBaseline and 4 months

Secondary

MeasureTime frame
zinc, vitamin A and vitamin C statusBaseline and 4 months
Weight, height, CRP and frequency of illnessBaseline and 4 months
Dietary intakeBaseline and 4 months

Countries

Philippines

Contacts

Primary ContactImelda Angeles-Agdeppa, PhD
imelda_agdeppa@yahoo.com011-63-2-8372071
Backup ContactMa. Lilibeth P Dasco, RND
mlpd@fnri.dost.gov.ph011-63-2-8372071

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026