Please select the eligibility criteria that correspond to the clinical trial below.
Title: Development and Health of Rural Chinese Children Fed Meat as a Daily Complementary Food From 6-18 Mos of Age
Brief Summary: Inadequate feeding of infants and toddlers impairs physical and cognitive development and is a major contributor to early childhood infectious disease illnesses and preventable mortality. Optimal feeding has two broad components: Exclusive breast feeding (EBF) for the first-6 months followed by continued breast feeding accompanied by complementary foods (CF) that is adequate in quantity and quality. While EBF is theoretically straightforward, CF is more complex. This is because CF is typically limited mainly or entirely to plant-based foods in developing countries worldwide. Dependence on adequate, affordable locally-produced foods for complete CF requires an inexpensive, regular source of meat especially to provide 'problem' micronutrients, notably, but not only, zinc and bioavailable iron. While the use of micronutrient-fortified CF and of supplements, including SprinklesTM, is spreading, their efficacy largely remains uncertain as does their availability, particularly on a sustainable, affordable basis Achievement of the widespread regular use of meat as a CF requires: (1) adequate local production of affordable small scavenging/foraging animals in poor rural and, where feasible, periurban communities worldwide; (2) effective communication for behavioral change/education so that young children, starting at age 6 months (when meat is readily accepted by infants), receive priority in the use of this meat. Solid scientific evidence of the value of international/national programs to achieve this goal is essential to provide the basis and incentive for major international and national programs to promote the feeding of meat as an early and regular CF. The acquisition of such evidence is the goal of this study

The intervention to be evaluated is meat fed daily as a complementary food from age 6-18 months. Thirty infants-toddlers in each of 60 rural communities (total of 1,800 subjects) will participate. In a cluster design, twenty communities (test) will be randomized to receive meat,twenty communities (control) will receive a plant recipe providing the same amount of calories, twenty communities (fortified cereal) will receive a commercially available fortified cereal providing the same amount of calories. This project will be located in rural China in a county where high quality collaboration is already established, and where we have recently demonstrated inadequate bioavailable zinc intake and zinc deficiency in toddlers. We have also found a high (30%) incidence of stunting, now widely used as an indirect indicator of populations with zinc deficiency. Other advantages of this location include the willingness of doctors located in each rural community to provide the test or control meal 7 days per week in their homes and the absence of any access to supplements / fortified products which could complicate interpretation of data. The young children in the test communities will receive certified safe lean pork 7 days per wk. Starting with a very small quantity at 6 months, the quantity of lean pork will be increased as infants are ready to take more up to a plateau of 2 oz/d. No subsequent increases are planned because neither zinc nor iron requirements increase from 6-11 months to 12-18 months. Lean pork will be used because pigs are ubiquitous in China and can be maintained cheaply by scavenging/foraging on waste materials adjacent to human habitation. Test and control clusters will also receive nutrition education to achieve maximal diversification of locally available affordable foods. Longitudinal outcome measures include indices of physical growth, especially length; infectious disease incidence and prevalence; cognitive development; zinc and iron intake and biomarkers for these and other micronutrients. Zinc absorption will be measured. Data will flow daily from communities to the district hospital in Xi-Chou, weekly to the data manager in Shanghai and 3-monthly to the Data Monitoring Safety Board (DSMB) and to the University of Colorado research group.


Options:
A: Inclusion Criteria:

* child is healthy and between the age of 6 months to 9 months

Exclusion Criteria:

* age of child
* any reactions to eating to eggs, a rash, hives, difficulty breathing
B: 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).
C: Inclusion Criteria:

* Infants born in study communities who will reach 6 months of age during the six month period after initiation of the study

Exclusion Criteria:

* Infants likely to receive free or subsidized complementary foods (or infant formula)
* Families likely to relocate during the study period
* Infants with known congenital anomaly
* Infants of multiple birth
* Infants with neurological deficit apparent at the time of enrollment
D: Inclusion Criteria:

* 3 months of age

Exclusion Criteria:

* birth wt \<2000 g
* any chronic disease or condition that affects growth
* not breastfed

Answer: D