Efficacy of Vitamin A in Fortified Extruded Rice in School Children

This study has been completed.
Sponsor:
Collaborators:
Mahidol University
University of Wisconsin, Madison
Information provided by (Responsible Party):
Richard Hurrell, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier:
NCT01199445
First received: August 20, 2010
Last updated: June 29, 2012
Last verified: June 2012
  Purpose

The project aims to evaluate the potential impact triple fortified rice grains, mixed into natural rice grains, can have on vitamin A status if fed to school children in Southern Thailand. Within a 60 day intervention study, changes in vitamin A status in young children fed the fortified rice compared to children consuming non-fortified rice will be assessed.


Condition Intervention Phase
Vitamin A Deficiency
Dietary Supplement: Triple fortified extruded tice (Fe, Zn and vitamin A)
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Efficacy of Vitamin A in Fortified Extruded Rice in School Children in Satun, Thailand

Resource links provided by NLM:


Further study details as provided by Swiss Federal Institute of Technology:

Primary Outcome Measures:
  • Vitamin A in the entire body [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    A quantitative estimate of the size of exchangeable body pool of vitamin A. The exchangeable body pool of vitamin A refer to the vitamin A in body that is in dynamic state.


Secondary Outcome Measures:
  • Serum retinol [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: August 2010
Study Completion Date: March 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: triple fortified extruded rice Dietary Supplement: Triple fortified extruded tice (Fe, Zn and vitamin A)
Triple fortified extruded rice (Fe, Zn and vitamin A)will be mix at ratio of 1:50 with normal rice then give to children at school lunch meal for 60 days.
regular meal
regular vitamin A meal
Dietary Supplement: Triple fortified extruded tice (Fe, Zn and vitamin A)
Triple fortified extruded rice (Fe, Zn and vitamin A)will be mix at ratio of 1:50 with normal rice then give to children at school lunch meal for 60 days.

Detailed Description:

Iron, zinc and vitamin A deficiencies are particularly common among children and young women in developing countries of South and Southeast Asia. Rice is a common staple for a large part of these sub-regions of Asia. In spite of a wide range of rice varieties eaten, rice is eaten by all age groups and is one of the first few foods used as complementary food for infants.

Fe fortification of rice using a method of heat extrusion and micronized ferric pyrophosphate (FePP) as iron fortificant has shown to be efficacious in increasing iron stores and reducing the prevalence of iron deficiency in Indian school children. Subsequent extrusion trials have shown promising results with respect to color and vitamin A (VA) stability when rice grains were triple fortified with Fe, Zn and vitamin A.

Preliminary data in the region of Satun, South Thailand, have shown that zinc and vitamin A intakes are low. Biochemical indicators have confirmed zinc deficiency and suboptimal vitamin A status in 1/3 of school aged children. Since rice is the main staple food in this area, rice triple fortified with Fe, VA and Zn is a promising strategy to combat micronutrient deficiencies in children.

The aim of this study is to demonstrate whether triple fortified rice has an impact on vitamin A status of children. The study will be conducted in school children (8 to 12 years old). The children will be randomized to either receive a daily lunch rice meal prepared from fortified rice (the triple fortified rice grains will be mixed into natural rice at a ratio of 1:50) or from non-fortified rice for 60 days. As serum retinol concentration, the most widely used indicator for the assessment of vitamin A status, is not a very reliable indicator due to homeostatic control and the influence of infection, we will in addition use the tracer methodology using dilution of stable isotopes with which total body vitamin A pool size will be estimated prior to the intervention and after 60 days of the intervention..

  Eligibility

Ages Eligible for Study:   8 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children, aged 8-12 years, both sexes, attending the local primary schools
  • No known or reported history of significant chronic illness
  • Free of acute illness and febrile and gastrointestinal problems

Exclusion Criteria:

  • Children with severe vitamin A deficiency with a clinical sign of Bioit's spot or ocular signs of xerophthalmia will be excluded
  • Children who have serum retinol < 0.7 umol/L
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01199445

Locations
Thailand
Tessaban 3 School
Muang, Satun, Thailand, 91000
Sponsors and Collaborators
Swiss Federal Institute of Technology
Mahidol University
University of Wisconsin, Madison
Investigators
Principal Investigator: Richard F Hurrell, Ph.D Swiss Federal Institute of Technology (ETH,Zurich)
  More Information

No publications provided by Swiss Federal Institute of Technology

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Richard Hurrell, Prof., Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT01199445     History of Changes
Other Study ID Numbers: ETH2010/SP02
Study First Received: August 20, 2010
Last Updated: June 29, 2012
Health Authority: Switzerland: Ethikkommission
Thailand: Ethical Committee

Keywords provided by Swiss Federal Institute of Technology:
vitamin A deficiency

Additional relevant MeSH terms:
Vitamin A Deficiency
Night Blindness
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vision Disorders
Eye Diseases
Vitamin A
Vitamins
Retinol palmitate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 01, 2014