Please select the eligibility criteria that correspond 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: 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%).
B: Inclusion Criteria:

* Children aged 12-36 months at enrollment
* Resident of Sangam Vihar and likely to be in the area for 1 year.
* Parents consenting to participate in the trial.

Exclusion Criteria:

* Children who have been given complete therapeutic/preventive course of Iron in the last 6 months.
* Children currently as part of a different Iron/Zinc supplementation program.
* Children known to be allergic to milk.
* Children who are severely malnourished and requiring hospitalization.
C: Inclusion Criteria:

* signed informed consent by parent / caretaker
* age between 6 and 14 yrs
* visiting selected school
* taking part in school meal program

Exclusion Criteria:

* any chronic illness affecting growth (such as HIV)
* no informed consent
* severe anemia which will require direct treatment
D: Inclusion Criteria:

* Inclusion criteria for clusters: Each cluster will be a rural community characterized by inhabitants with low income and served by one community health center. A primary criterion is that national or other available statistics indicate a prevalence of stunting (mean length for age Z-scores in second year \< -2) of at least 20% in young children.
* Inclusion criteria for individual families:

  * Infant aged 3-4 months;
  * Primarily or exclusively breast feeding with intent to continue breast feeding through at least 1 year.

Exclusion Criteria:

* Exclusion criteria for individual families: Exclusion criteria include any population/family that is receiving or likely to receive free or subsidized complementary foods (or infant formula) through the health system or NGOs; any individual families who are feeding or intend to feed fortified infant formula or micronutrient-fortified commercial complementary foods.
* Exclusion criteria for infants: Infants meeting the following criteria will be excluded from participation:

  1. known congenital anomaly;
  2. infant of multiple births;
  3. known neurological deficit apparent at the time of enrollment (including seizures).

Answer: A