Nutrient Fortified Oat Drink | NCT01418898

Studies
Nutrient Fortified Oat Drink

NCT01418898

Sponsor

PepsiCo Global R&D

Status

Unknown status

Last Update Posted

Aug 17, 2011Estimated

Enrollment

80Estimated

Phase

Phase 4

Conditions

Iron Deficiency Anemia

Interventions

Dietary Intervention

Countries

Philippines

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Dec 2011Estimated

Completion Date

Apr 2012Estimated

First Submitted Date

Aug 15, 2011

First Submission Date that Met QC Criteria

Aug 16, 2011

First Posted Date

Aug 17, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 16, 2011

Last Update Posted Date

Aug 17, 2011Estimated

Name	Class
PepsiCo - Philippines	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nutrient Fortified Beverage	Experimental		Other: Dietary Intervention
Control	Placebo Comparator		Other: Dietary Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dietary Intervention	Other	Nutrient fortified oat beverage	Control Nutrient Fortified Beverage

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Iron status: Change in hemoglobin and serum ferritin		Baseline and 4 months

Secondary Outcomes

Measure	Description	Time Frame
zinc, vitamin A and vitamin C status		Baseline and 4 months
Weight, height, CRP and frequency of illness		Baseline and 4 months
Dietary intake

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

7 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Imelda Angeles-Agdeppa, PhD	Contact	011-63-2-8372071	2280	imelda_agdeppa@yahoo.com
Ma. Lilibeth P Dasco, RND	Contact	011-63-2-8372071	2280	mlpd@fnri.dost.gov.ph

Overall Officials

Name	Affiliation	Role
Imelda Angeles-Agdeppa, PhD	FNRI	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
FNRI	Recruiting	City of Taguig			Philippines

Condition Browse Module

MeSH Terms

ID	Term
D018798	Anemia, Iron-Deficiency

Ancestor Terms

ID	Term
D000747	Anemia, Hypochromic
D000740	Anemia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004035	Diet Therapy

Ancestor Terms

ID	Term
D044623	Nutrition Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided