An Efficacy Trial of Iron, Zinc and Vitamin A Fortified Rice in Children in Satun, Thailand

Iron Deficiency Clinical Trial

Official title:

An Efficacy Trial of Fe, Zn and Vitamin A Fortified Rice in Children in Satun, Thailand

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01061307
• Other study ID #: ETH2010/1
• Status: Completed
• Phase: Phase 0
• First received: February 2, 2010
• Last updated: January 5, 2016
• Start date: September 2009
• Est. completion date: June 2010

Study information

• Verified date: April 2012
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

Iron, zinc and vitamin A deficiencies are particularly common among children and young women in the developing countries of South and Southeast Asia resulting in important adverse health effects. Simultaneous fortification of rice with iron, zinc and vitamin A could be a novel and sustainable approach to control these deficiencies.

Recently conducted extrusion trials have demonstrated that extruded rice grains containing iron, zinc and vitamin A show acceptable stability during production and storage and good sensory properties. The grains were produced using a twin-screw extruder equipped with a special cutter and a rice shaping die. The Fe, Zn and vitamin A content of the extruded product is 10 mg, 9 mg and 1050 μg per g of rice, respectively.

In this study the investigators plan to test the efficacy of the extruded triple fortified rice in Satun, Thailand, an area where rice is the staple food. Preliminary data from this area show 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. The efficacy of the fortified rice will be evaluated in a 9 months, controlled, double-blind intervention trial in 7-12 y-old children. Children will be selected from primary schools in Satun Province based on low serum zinc values as the primary goal is to investigate Zn efficacy. As secondary outcome the effect on iron and vitamin A status will be investigated. The children will be randomized into two groups: a control group will receive a daily non-fortified rice lunch meal at school, while the second group will receive a daily rice meal containing the triple fortified rice. The rice meals will be given 5 days a week. At baseline, weight and height will be measured and determination of hemoglobin, serum ferritin, zinc protoporphyrin, serum zinc, serum retinol and C-reactive protein will be done. At mid-point and at 9 months, the baseline measurements will be repeated to judge the efficacy of the triple fortified rice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: June 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 12 Years

Eligibility

Inclusion Criteria:

• Preliminary screening: 650 children of 7-12 y-old children attending the primary school serving a low-income area in Muang district , Satun.(no exclusion criteria).

• Efficacy trial: 180-200 children, children with the Zn deficiency (serum zinc < 65, 66 and 70 µg/dL in children < 10y, male = 10y and female = 10y)

Exclusion Criteria:

• Children showing severe iron, zinc or vitamin A deficiency. These children will be excluded from the study and treated according to local policies.

• Significant chronic medical illness, including gastrointestinal, hematological, hepatic or renal disorders.

• Low school attendance (<80%).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency
• Night Blindness
• Vitamin A Deficiency
• Zinc Deficiency

Intervention

Dietary Supplement:
• fortified extruded rice
fortified extruded rice (Fe, Zn and vitamin A) at the ratio 1:50 with normal rice

Locations

Country	Name	City	State
Switzerland	Swiss Federal Institute of Technology Zurich	Zurich
Thailand	Institute of Nutrition Mahidol University	Phuttamonthon	Nakhon Pathom

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	Mahidol University

Countries where clinical trial is conducted

Switzerland,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum Zn		September 2009-March 2010	No
Primary	Hemoglobin		September 2009-2010	No
Primary	serum retinol		September 2009-March 2010	No
Primary	serum ferritin		September 2009-March 2010	No
Primary	ZPP		September 2009- March 2010	No
Secondary	Anthropometry measures		September 2009-March 2010	No