Nutrient Fortified Oat Drink
Phase 4
- Conditions
- Iron Deficiency Anemia
- Interventions
- Other: Dietary Intervention
- Registration Number
- NCT01418898
- Lead Sponsor
- PepsiCo Global R&D
- 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 available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nutrient Fortified Beverage Dietary Intervention - Control Dietary Intervention -
- Primary Outcome Measures
Name Time Method Iron status: Change in hemoglobin and serum ferritin Baseline and 4 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
FNRI
🇵🇭Taguig City, Philippines