Nutrient Fortified Oat Drink
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ClinicalTrials.gov Identifier: NCT01418898 |
Recruitment Status
: Unknown
Verified August 2011 by PepsiCo Global R&D.
Recruitment status was: Recruiting
First Posted
: August 17, 2011
Last Update Posted
: August 17, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Iron Deficiency Anemia | Other: Dietary Intervention | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, 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 |
Study Start Date : | August 2011 |
Estimated Primary Completion Date : | December 2011 |
Estimated Study Completion Date : | April 2012 |
Arm | Intervention/treatment |
---|---|
Experimental: Nutrient Fortified Beverage |
Other: Dietary Intervention
Nutrient fortified oat beverage
|
Placebo Comparator: Control |
Other: Dietary Intervention
Nutrient fortified oat beverage
|
- Iron status: Change in hemoglobin and serum ferritin [ Time Frame: Baseline and 4 months ]
- zinc, vitamin A and vitamin C status [ Time Frame: Baseline and 4 months ]
- Weight, height, CRP and frequency of illness [ Time Frame: Baseline and 4 months ]
- Dietary intake [ Time Frame: Baseline and 4 months ]

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Ages Eligible for Study: | 5 Years to 7 Years (Child) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01418898
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 |
Philippines | |
FNRI | Recruiting |
Taguig City, Philippines | |
Contact: Angeles-Agdeppa 011-63-2-8372071 ext 2280 | |
Principal Investigator: Imelda Angeles-Agdeppa, PhD |
Principal Investigator: | Imelda Angeles-Agdeppa, PhD | FNRI |
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 |
First Posted: | August 17, 2011 Key Record Dates |
Last Update Posted: | August 17, 2011 |
Last Verified: | August 2011 |
Keywords provided by PepsiCo Global R&D:
Iron deficiency anemia iron zinc |
vitamin A vitamin C oats |
Additional relevant MeSH terms:
Anemia, Iron-Deficiency Anemia, Hypochromic Anemia Hematologic Diseases Iron Metabolism Disorders Metabolic Diseases |
Vitamins Vitamin A Micronutrients Growth Substances Physiological Effects of Drugs |