Development and Health of Rural Chinese Children Fed Meat as a Daily Complementary Food From 6-18 Mos of Age

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00726102
Recruitment Status : Completed
First Posted : July 31, 2008
Last Update Posted : April 28, 2016
Shanghai Jiao Tong University School of Medicine
Xi-Chou Women and Children's Hospital
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Nutritional Deficiencies Other: Meat Other: Cereal Other: fortified rice cereal Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1488 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Development and Health of Rural Chinese Children Fed Meat as a Daily Complementary Food From 6-18 Mos of Age
Study Start Date : November 2008
Actual Primary Completion Date : May 2012
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Meat
Provide locally available meat daily to infants from 6 to 18 mos of age
Other: Meat
2 0z of locally available meat per day

Active Comparator: Control
Daily provision of cereal to infants from 6-18 mos
Other: Cereal
Daily provision of cereal to infants from 6-18 mos

Active Comparator: Fortified rice cereal
Provide equi-caloric serving of fortified rice cereal on daily basis from 6-18 months of age
Other: fortified rice cereal
Daily provision of fortified cereal to infants 6-18 months of age

Primary Outcome Measures :
  1. Linear Growth [ Time Frame: 6-18 mos of age ]

Secondary Outcome Measures :
  1. Morbidity [ Time Frame: 6-18 mos of age ]
  2. Cognitive development [ Time Frame: 0-18 mo of age ]
  3. Zn absorption [ Time Frame: 9 and 18 mos of age ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 3 months of age

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00726102

United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Shanghai Jiao Tong University School of Medicine
Xi-Chou Women and Children's Hospital
Principal Investigator: Michael Hambidge, MD University of Colorado, Denver

Responsible Party: University of Colorado, Denver Identifier: NCT00726102     History of Changes
Other Study ID Numbers: 08-0768
First Posted: July 31, 2008    Key Record Dates
Last Update Posted: April 28, 2016
Last Verified: April 2016

Keywords provided by University of Colorado, Denver:
Zinc nutrition

Additional relevant MeSH terms:
Nutrition Disorders