NCT01084109

Brief Summary

The specific aims of this project is to determine the impact of a daily intake of one half ounce of lyophilized meat between 6-18 months of age (0.5 oz for 6-12 mo; 0.75 oz for 12-18 mo) on linear growth velocity, zinc and iron intakes and status, brain growth and neurocognitive development, and infectious disease morbidity in populations traditionally dependent on non-micronutrient fortified plant foods for complementary feeding.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,236

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2008

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 10, 2010

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

Enrollment Period

1.8 years

First QC Date

March 9, 2010

Last Update Submit

November 22, 2013

Conditions

Complementary FeedingInfant Growth

Keywords

Complementary feedingInfant growthDeveloping countries

Outcome Measures

Primary Outcomes (1)

  • Linear growth velocity

    6 to 18 months of age

Secondary Outcomes (3)

  • Infant Zinc and Ferritin levels

    18 months

  • Bayleys II

    18 months

  • Incidence of diarrhea, lower respiratory infection, and malaria

    6 to 18 months

Study Arms (2)

1

ACTIVE COMPARATOR

Daily intake of one half ounce of lyophilized meat between 6-18 months of age (0.5 oz for 6-12 mo; 0.75 oz for 12-18 mo)

Other: Lyophilized meat

2

ACTIVE COMPARATOR

Daily intake of an equi-caloric fortified cereal as complementary feed from 6 to 18 months.

Other: Cereal

Interventions

Lyophilized meatOTHER

Daily intake of one half ounce of lyophilized meat between 6-18 months of age (0.5 oz for 6-12 mo; 0.75 oz for 12-18 mo)

1
CerealOTHER

Daily intake of an equi-caloric fortified cereal as complementary feed from 6 to 18 months.

2

Eligibility Criteria

Age3 Months - 4 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Institute for Nutrition of Central America and Panama (INCAP)

Chiimaltenango, Guatemala

Location

Agha Khan University

Karachi, Pakistan

Location

Kinshasa School of Public Health

Karawa, Republic of the Congo

Location

University of Zambia

Lusaka, Zambia

Location

Related Publications (3)

  • Manasyan A, Salas AA, Nolen T, Chomba E, Mazariegos M, Tshefu Kitoto A, Saleem S, Naqvi F, Hambidge KM, Goco N, McClure EM, Wallander JL, Biasini FJ, Goldenberg RL, Bose CL, Koso-Thomas M, Krebs NF, Carlo WA. Diagnostic accuracy of ASQ for screening of neurodevelopmental delays in low resource countries. BMJ Open. 2023 May 23;13(5):e065076. doi: 10.1136/bmjopen-2022-065076.

    PMID: 37221030DERIVED

  • Krebs NF, Mazariegos M, Chomba E, Sami N, Pasha O, Tshefu A, Carlo WA, Goldenberg RL, Bose CL, Wright LL, Koso-Thomas M, Goco N, Kindem M, McClure EM, Westcott J, Garces A, Lokangaka A, Manasyan A, Imenda E, Hartwell TD, Hambidge KM. Randomized controlled trial of meat compared with multimicronutrient-fortified cereal in infants and toddlers with high stunting rates in diverse settings. Am J Clin Nutr. 2012 Oct;96(4):840-7. doi: 10.3945/ajcn.112.041962. Epub 2012 Sep 5.

    PMID: 22952176DERIVED

  • Krebs NF, Hambidge KM, Mazariegos M, Westcott J, Goco N, Wright LL, Koso-Thomas M, Tshefu A, Bose C, Pasha O, Goldenberg R, Chomba E, Carlo W, Kindem M, Das A, Hartwell T, McClure E; Complementary Feeding Study Group. Complementary feeding: a Global Network cluster randomized controlled trial. BMC Pediatr. 2011 Jan 13;11:4. doi: 10.1186/1471-2431-11-4.

    PMID: 21232139DERIVED

MeSH Terms

Interventions

Edible Grain

Intervention Hierarchy (Ancestors)

Crops, AgriculturalFoodDiet, Food, and NutritionPhysiological PhenomenaSeedsFood and Beverages

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2010

First Posted

March 10, 2010

Study Start

July 1, 2008

Primary Completion

April 1, 2010

Study Completion

July 1, 2010

Last Updated

November 25, 2013

Record last verified: 2013-11

Locations

RE(1)GU(1)PA(1)ZA(1)