Nutrient Fortified Oat Drink

NCT01418898 | Unknown Phase 4

• 1 other identifier: PEP 1011
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron Deficiency Anemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Iron status: Change in hemoglobin and serum ferritin

  Baseline and 4 months

Secondary Outcomes (3)

• 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

Study Arms (2)

Nutrient Fortified Beverage

EXPERIMENTAL

Other: Dietary Intervention

Control

PLACEBO COMPARATOR

Other: Dietary Intervention

Interventions

Dietary Intervention OTHER

Nutrient fortified oat beverage

Control; Nutrient Fortified Beverage

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PepsiCo Global R&D: lead
• PepsiCo - Philippines: collaborator

Study Sites (1)

FNRI

City of Taguig, Philippines

RECRUITING

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Imelda Angeles-Agdeppa, PhD

  FNRI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imelda Angeles-Agdeppa, PhD

CONTACT

011-63-2-8372071; imelda_agdeppa@yahoo.com

Ma. Lilibeth P Dasco, RND

CONTACT

011-63-2-8372071; mlpd@fnri.dost.gov.ph

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 15, 2011
• First Posted: August 17, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: April 1, 2012
• Last Updated: August 17, 2011

Record last verified: 2011-08

Locations

PH (1)