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Cracking the Egg Potential: Improving Young Child Nutrition in Ecuador

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ClinicalTrials.gov Identifier: NCT02446873
Recruitment Status : Completed
First Posted : May 18, 2015
Last Update Posted : June 19, 2018
Sponsor:
Collaborators:
Universidad San Francisco de Quito
Pan American Health Organization
University of California, Davis
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
The proposed study will fill an important gap in the literature by examining, through a randomized controlled trial, the effect of egg consumption on biochemical markers of choline, vitamin B-12, lipids, and amino acids in young children in a poor rural area of Ecuador. Children from Cotopaxi Province, Ecuador (n=180) will be randomized into one of two groups: 1) intervention, receiving one egg per day for six months; or 2) control. Baseline and endline data on socio-economic factors, and child diet, morbidities, and anthropometry will be collected. Blood will also be drawn from the children at these time points for nutrient biomarker analyses. Through qualitative research the proposed study will provide insight into the attitudes, beliefs, and use of eggs by mothers and other caregivers during the complementary feeding period. The University of San Francisco in Quito (USFQ) will be the lead field coordinator of the research working in partnership with Washington University in St. Louis, Pan-American Health Organization (PAHO) and University of California, Davis.

Condition or disease Intervention/treatment Phase
Choline Deficiency Vitamin B-12 Deficiency Lipids Deficiency Amino Acids Deficiency Other: Egg supplementation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 171 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cracking the Egg Potential: Improving Young Child Nutrition in Ecuador
Study Start Date : February 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Child Nutrition

Arm Intervention/treatment
No Intervention: Control
Control group
Experimental: Treatment
Egg supplementation
Other: Egg supplementation
A weekly supply of eggs will be given to the mother in the egg supplementation group with instructions to give the child one egg per day.




Primary Outcome Measures :
  1. Serum/plasma concentrations of B12, choline, and betaine [ Time Frame: 6 months ]
    Venous blood collection

  2. Serum/plasma concentrations of polyunsaturated fatty acids (PUFAs) and amino acids [ Time Frame: 6 months ]
    Venous blood collection


Secondary Outcome Measures :
  1. Attitudes, beliefs, and use of eggs in Pastocalle during the complementary feeding period. [ Time Frame: 6 months ]
    Qualitative assessments: focus groups; in-depth interviews

  2. Frequency of consumption of eggs, other animal source foods, and dietary diversity more broadly in the child's diet in Pastocalle. [ Time Frame: 6 months ]
    Household survey



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 9 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT02446873


Locations
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Ecuador
Pastocalle Parish
Pastocalle, Cotopaxi Province, Ecuador
Sponsors and Collaborators
Washington University School of Medicine
Universidad San Francisco de Quito
Pan American Health Organization
University of California, Davis
Investigators
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Principal Investigator: Lora Iannotti, PhD Washington University School of Medicine

Publications:
Charmaz, K, 1995, 'Grounded theory' in Rethinking methods in psychology.'
Charmaz, K, 2000, 'Grounded theory: Objectivist and constructivist methods' in Handbook of qualitative research (2nd Edition).
Clarke, A, 2005, 'Situational analysis: Grounded theory after the postmodern turn.'
Davies, R, and Dart, J, 2005, The 'Most Significant Change' (MSC) Technique. Guide to Its Use Gibson RS. Principles of nutrition assessment. 2nd ed. New York: Oxford University Press; 2005.
Hedeker D, Gibbons R. Longitudinal Data Analysis. 1st ed. Hoboken, NJ: Wiley, John & Sons, Incorporated; 2006.
Lofland, J. and Lofland, L, 1995. Analyzing Social Settings: A Guide to Qualitative Observation and Analysis. Belmont, CA: Wadsworth.
Reichertz, Jo (2009). Abduction: The Logic of Discovery of Grounded Theory [39 paragraphs]. Forum Qualitative Sozialforschung / Forum: Qualitative Social Research, 11(1), Art. 13.
Strauss and Corbin, 1994, 'Grounded theory methodology: An overview' in Handbook of qualitative research (1st Edition).
Strauss and Corbin 1998, Basics of qualitative research: Grounded theory procedures and techniques (2nd Edition).
World Health Organization (WHO). The WHO Child Growth Standards. Version current 1 April 2013. Internet: http://www.who.int/childgrowth/en/.
World Health Organization (WHO). Indicators for assessing infant and young child feeding practices Part 1.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02446873     History of Changes
Other Study ID Numbers: 201409108
First Posted: May 18, 2015    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018
Keywords provided by Washington University School of Medicine:
children
Ecuador
rural
poor
Additional relevant MeSH terms:
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Vitamin B 12 Deficiency
Choline Deficiency
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders