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

NCT01061307 | Completed Early Phase 1

• 1 other identifier: ETH2010/1
• Study Type: interventional
• Target: 203
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Vitamin A Deficiency; Iron Deficiency; Zinc Deficiency

Keywords

Fe deficiency, Zn deficiency, vitamin A deficiency

Outcome Measures

Primary Outcomes (5)

• serum Zn

  September 2009-March 2010

• Hemoglobin

  September 2009-2010

• serum retinol

  September 2009-March 2010

• serum ferritin

  September 2009-March 2010

• ZPP

  September 2009- March 2010

Secondary Outcomes (1)

• Anthropometry measures

  September 2009-March 2010

Study Arms (1)

fortified extruded rice

EXPERIMENTAL

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

Dietary Supplement: fortified extruded rice

Interventions

fortified extruded rice DIETARY_SUPPLEMENT

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

fortified extruded rice

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may not qualify if:

• 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)
• 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%).

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• Mahidol University: collaborator

Study Sites (2)

Swiss Federal Institute of Technology Zurich

Zurich, 8092, Switzerland

Location

Institute of Nutrition Mahidol University

Phuttamonthon, Changwat Nakhon Pathom, 73170, Thailand

Location

Related Publications (2)

• Suri DJ, Tanumihardjo JP, Gannon BM, Pinkaew S, Kaliwile C, Chileshe J, Tanumihardjo SA. Serum retinol concentrations demonstrate high specificity after correcting for inflammation but questionable sensitivity compared with liver stores calculated from isotope dilution in determining vitamin A deficiency in Thai and Zambian children. Am J Clin Nutr. 2015 Nov;102(5):1259-65. doi: 10.3945/ajcn.115.113050. Epub 2015 Oct 7.

  PMID: 26447158 DERIVED

• Pinkaew S, Winichagoon P, Hurrell RF, Wegmuller R. Extruded rice grains fortified with zinc, iron, and vitamin A increase zinc status of Thai school children when incorporated into a school lunch program. J Nutr. 2013 Mar;143(3):362-8. doi: 10.3945/jn.112.166058. Epub 2013 Jan 9.

  PMID: 23303870 DERIVED

MeSH Terms

Conditions

Vitamin A Deficiency; Iron Deficiencies

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Iron Metabolism Disorders; Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2010
• First Posted: February 3, 2010
• Study Start: September 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: June 1, 2010
• Last Updated: January 6, 2016

Record last verified: 2012-04

Locations

TH (1); CH (1)