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Nutrient Fortified Oat Drink

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PepsiCo

Status and phase

Unknown
Phase 4

Conditions

Iron Deficiency Anemia

Treatments

Other: Dietary Intervention

Study type

Interventional

Funder types

Industry
Other

Identifiers

NCT01418898
PEP 1011

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

5 to 7 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

80 participants in 2 patient groups, including a placebo group

Nutrient Fortified Beverage
Experimental group
Treatment:
Other: Dietary Intervention
Control
Placebo Comparator group
Treatment:
Other: Dietary Intervention

Trial contacts and locations

1

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Central trial contact

Imelda Angeles-Agdeppa, PhD; Ma. Lilibeth P Dasco, RND

Data sourced from clinicaltrials.gov

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