Nutrient Fortified Oat Drink
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by PepsiCo Global R&D.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
PepsiCo Global R&D
Collaborator:
PepsiCo - Philippines
Information provided by:
PepsiCo Global R&D
ClinicalTrials.gov Identifier:
NCT01418898
First received: August 15, 2011
Last updated: August 16, 2011
Last verified: August 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Iron Deficiency Anemia |
Other: Dietary Intervention |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Effect of a Nutrient Fortified Oat Drink on Iron, Zinc, Vitamin A, and Vitamin C Status Among Filipino Children |
Resource links provided by NLM:
Further study details as provided by PepsiCo Global R&D:
Primary Outcome Measures:
- Iron status: Change in hemoglobin and serum ferritin [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- zinc, vitamin A and vitamin C status [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]
- Weight, height, CRP and frequency of illness [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]
- Dietary intake [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | April 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Nutrient Fortified Beverage |
Other: Dietary Intervention
Nutrient fortified oat beverage
|
| Placebo Comparator: Control |
Other: Dietary Intervention
Nutrient fortified oat beverage
|
Eligibility| Ages Eligible for Study: | 5 Years to 7 Years (Child) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01418898
Please refer to this study by its ClinicalTrials.gov identifier: NCT01418898
Contacts
| Contact: Imelda Angeles-Agdeppa, PhD | 011-63-2-8372071 ext 2280 | imelda_agdeppa@yahoo.com | |
| Contact: Ma. Lilibeth P Dasco, RND | 011-63-2-8372071 ext 2280 | mlpd@fnri.dost.gov.ph |
Locations
| Philippines | |
| FNRI | Recruiting |
| Taguig City, Philippines | |
| Contact: Angeles-Agdeppa 011-63-2-8372071 ext 2280 | |
| Principal Investigator: Imelda Angeles-Agdeppa, PhD | |
Sponsors and Collaborators
PepsiCo Global R&D
PepsiCo - Philippines
Investigators
| Principal Investigator: | Imelda Angeles-Agdeppa, PhD | FNRI |
More Information
| Responsible Party: | Imelda Angeles-Agdeppa, Ph.D, Food and Nutrition Research Institute Department of Science and Technology |
| ClinicalTrials.gov Identifier: | NCT01418898 History of Changes |
| Other Study ID Numbers: | PEP 1011 |
| Study First Received: | August 15, 2011 |
| Last Updated: | August 16, 2011 |
| Health Authority: | Philippines: Ethics Committee |
Keywords provided by PepsiCo Global R&D:
|
Iron deficiency anemia iron zinc |
vitamin A vitamin C oats |
Additional relevant MeSH terms:
|
Vitamin A Anemia, Iron-Deficiency Deficiency Diseases Anemia Anemia, Hypochromic Hematologic Diseases Iron Metabolism Disorders |
Metabolic Diseases Malnutrition Nutrition Disorders Vitamins Micronutrients Growth Substances Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 28, 2016