An Early Phase 1 interventional study of fortified extruded rice in Vitamin A Deficiency, Iron Deficiency and Zinc Deficiency, sponsored by Swiss Federal Institute of Technology. Completed at 2 sites in 2 countries. Open to participants aged 7 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-01-06.
Sponsored by Swiss Federal Institute of Technology · Early Phase 1, Interventional, and Treatment
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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.
67 studies on the registry are indexed under Vitamin A Deficiency; 7 are open to participants now.
This study's enrollment of 203 is close to the median of 200 across 49 interventional studies indexed under Vitamin A Deficiency.
Browse Vitamin A Deficiency studies →Swiss Federal Institute of Technology is the lead sponsor of 154 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
fortified extruded rice (Fe, Zn and vitamin A) at the ratio 1:50 with normal rice
Dietary Supplement: fortified extruded rice
fortified extruded rice (Fe, Zn and vitamin A) at the ratio 1:50 with normal rice
serum Zn
Time frame: September 2009-March 2010
Hemoglobin
Time frame: September 2009-2010
serum retinol
Time frame: September 2009-March 2010
serum ferritin
Time frame: September 2009-March 2010
ZPP
Time frame: September 2009- March 2010
Anthropometry measures
Time frame: September 2009-March 2010
The record gives a start of Sep 2009, a primary completion of Mar 2010 and a completion of Jun 2010. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.
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