Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: An Efficacy Trial of Fe, Zn and Vitamin A Fortified Rice in Children in Satun, Thailand
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.


Options:
A: Arm Label: fortified extruded rice; Type: EXPERIMENTAL; Interventions: Dietary Supplement: fortified extruded rice | Intervention Type: DIETARY_SUPPLEMENT; Name: fortified extruded rice; Assigned to Arm(s): fortified extruded rice
B: Intervention Type: DRUG; Name: Micronutrient (Zinc and Iron) fortification; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Pre and Probiotic fortification; Assigned to Arm(s): N/A
C: Arm Label: no school meal; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: normal school meal; Type: PLACEBO_COMPARATOR; Interventions: N/A | Arm Label: cold extruded fortified rice; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Fortified rice cold extruded kernel | Arm Label: warm extrusion; Type: EXPERIMENTAL; Interventions: Dietary Supplement: fortified rice warm extruded kernel | Arm Label: hot extruded; Type: EXPERIMENTAL; Interventions: Dietary Supplement: fortiified rice hot extruded kernel | Intervention Type: DIETARY_SUPPLEMENT; Name: Fortified rice cold extruded kernel; Assigned to Arm(s): cold extruded fortified rice | Intervention Type: DIETARY_SUPPLEMENT; Name: fortified rice warm extruded kernel; Assigned to Arm(s): warm extrusion | Intervention Type: DIETARY_SUPPLEMENT; Name: fortiified rice hot extruded kernel; Assigned to Arm(s): hot extruded
D: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Other: Lyophilized meat | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Other: Cereal | Intervention Type: OTHER; Name: Lyophilized meat; Assigned to Arm(s): 1 | Intervention Type: OTHER; Name: Cereal; Assigned to Arm(s): 2

Answer: A