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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Shanghai Jiao Tong University School of Medicine
Xi-Chou Women and Children's Hospital
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00726102
First received: July 28, 2008
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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 Intervention
Nutritional Deficiencies
Other: Meat
Other: Cereal
Other: fortified rice cereal

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Linear Growth [ Time Frame: 6-18 mos of age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • morbidity [ Time Frame: 6-18 mos of age ] [ Designated as safety issue: No ]
  • cognitive development [ Time Frame: 0-18 mo of age ] [ Designated as safety issue: No ]
  • Zn absorption [ Time Frame: 9 and 18 mos of age ] [ Designated as safety issue: No ]

Enrollment: 1488
Study Start Date: November 2008
Estimated Study Completion Date: December 2014
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 3 months of age

Exclusion Criteria:

  • birth wt <2000 g
  • any chronic disease or condition that affects growth
  • not breastfed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00726102

Locations
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
Investigators
Principal Investigator: Michael Hambidge, MD University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00726102     History of Changes
Other Study ID Numbers: 08-0768, Thrasher
Study First Received: July 28, 2008
Last Updated: December 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Zinc nutrition
Growth
Development
China
Infants
Toddlers

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on November 23, 2014