Cracking the Egg Potential: Improving Young Child Nutrition in Ecuador

NCT02446873 | Completed

• 1 other identifier: 201409108
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 1

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.

Conditions

Choline Deficiency; Vitamin B-12 Deficiency; Lipids Deficiency; Amino Acids Deficiency

Keywords

children; Ecuador; rural; poor

Outcome Measures

Primary Outcomes (2)

• Serum/plasma concentrations of B12, choline, and betaine

  Venous blood collection

  6 months

• Serum/plasma concentrations of polyunsaturated fatty acids (PUFAs) and amino acids

  Venous blood collection

  6 months

Secondary Outcomes (2)

• Attitudes, beliefs, and use of eggs in Pastocalle during the complementary feeding period.

  6 months

• Frequency of consumption of eggs, other animal source foods, and dietary diversity more broadly in the child's diet in Pastocalle.

  6 months

Study Arms (2)

Control

NO INTERVENTION

Control group

Treatment

EXPERIMENTAL

Egg supplementation

Other: Egg supplementation

Interventions

Egg supplementation OTHER

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.

Treatment

Eligibility Criteria

• Age: 6 Months - 9 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• age of child
• any reactions to eating to eggs, a rash, hives, difficulty breathing

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Universidad San Francisco de Quito: collaborator
• Pan American Health Organization: collaborator
• University of California, Davis: collaborator

Study Sites (1)

Pastocalle Parish

Pastocalle, Cotopaxi Province, Ecuador

Location

Related Publications (20)

• Charmaz, K, 1995, 'Grounded theory' in Rethinking methods in psychology.'

  BACKGROUND

• Charmaz, K, 2000, 'Grounded theory: Objectivist and constructivist methods' in Handbook of qualitative research (2nd Edition).

  BACKGROUND

• Charmaz, K, 2006, Constructing grounded theory: A practical guide through qualitative analysis.

  BACKGROUND

• Clarke, A, 2005, 'Situational analysis: Grounded theory after the postmodern turn.'

  BACKGROUND

• 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.

  BACKGROUND

• Guldan GS, Fan HC, Ma X, Ni ZZ, Xiang X, Tang MZ. Culturally appropriate nutrition education improves infant feeding and growth in rural Sichuan, China. J Nutr. 2000 May;130(5):1204-11. doi: 10.1093/jn/130.5.1204.

  PMID: 10801920 BACKGROUND

• Hedeker D, Gibbons R. Longitudinal Data Analysis. 1st ed. Hoboken, NJ: Wiley, John & Sons, Incorporated; 2006.

  BACKGROUND

• Iannotti LL, Lutter CK, Bunn DA, Stewart CP. Eggs: the uncracked potential for improving maternal and young child nutrition among the world's poor. Nutr Rev. 2014 Jun;72(6):355-68. doi: 10.1111/nure.12107. Epub 2014 May 7.

  PMID: 24807641 BACKGROUND

• Jones KM, Ramirez-Zea M, Zuleta C, Allen LH. Prevalent vitamin B-12 deficiency in twelve-month-old Guatemalan infants is predicted by maternal B-12 deficiency and infant diet. J Nutr. 2007 May;137(5):1307-13. doi: 10.1093/jn/137.5.1307.

  PMID: 17449597 BACKGROUND

• Lofland, J. and Lofland, L, 1995. Analyzing Social Settings: A Guide to Qualitative Observation and Analysis. Belmont, CA: Wadsworth.

  BACKGROUND

• Institute of Medicine (US) Panel on Micronutrients. Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc. Washington (DC): National Academies Press (US); 2001. Available from http://www.ncbi.nlm.nih.gov/books/NBK222310/

  PMID: 25057538 BACKGROUND

• Pelto GH, Armar-Klemesu M, Siekmann J, Schofield D. The focused ethnographic study 'assessing the behavioral and local market environment for improving the diets of infants and young children 6 to 23 months old' and its use in three countries. Matern Child Nutr. 2013 Jan;9 Suppl 1(Suppl 1):35-46. doi: 10.1111/j.1740-8709.2012.00451.x.

  PMID: 23167583 BACKGROUND

• Reichertz, Jo (2009). Abduction: The Logic of Discovery of Grounded Theory [39 paragraphs]. Forum Qualitative Sozialforschung / Forum: Qualitative Social Research, 11(1), Art. 13.

  BACKGROUND

• Strauss and Corbin, 1994, 'Grounded theory methodology: An overview' in Handbook of qualitative research (1st Edition).

  BACKGROUND

• Strauss and Corbin 1998, Basics of qualitative research: Grounded theory procedures and techniques (2nd Edition).

  BACKGROUND

• Taneja S, Strand TA, Kumar T, Mahesh M, Mohan S, Manger MS, Refsum H, Yajnik CS, Bhandari N. Folic acid and vitamin B-12 supplementation and common infections in 6-30-mo-old children in India: a randomized placebo-controlled trial. Am J Clin Nutr. 2013 Sep;98(3):731-7. doi: 10.3945/ajcn.113.059592. Epub 2013 Jul 31.

  PMID: 23902779 BACKGROUND

• World Health Organization (WHO). The WHO Child Growth Standards. Version current 1 April 2013. Internet: http://www.who.int/childgrowth/en/.

  BACKGROUND

• World Health Organization (WHO). Indicators for assessing infant and young child feeding practices Part 1.

  BACKGROUND

• Evers EC, Waters WF, Gallegos-Riofrio CA, Lutter CK, Stewart CP, Iannotti LL. A sex- and gender-based analysis of factors associated with linear growth in infants in Ecuadorian Andes. Sci Rep. 2022 Feb 28;12(1):3292. doi: 10.1038/s41598-022-06806-3.

  PMID: 35228574 DERIVED

• Iannotti LL, Lutter CK, Waters WF, Gallegos Riofrio CA, Malo C, Reinhart G, Palacios A, Karp C, Chapnick M, Cox K, Aguirre S, Narvaez L, Lopez F, Sidhu R, Kell P, Jiang X, Fujiwara H, Ory DS, Young R, Stewart CP. Eggs early in complementary feeding increase choline pathway biomarkers and DHA: a randomized controlled trial in Ecuador. Am J Clin Nutr. 2017 Dec;106(6):1482-1489. doi: 10.3945/ajcn.117.160515. Epub 2017 Nov 1.

  PMID: 29092879 DERIVED

MeSH Terms

Conditions

Choline Deficiency; Vitamin B 12 Deficiency

Condition Hierarchy (Ancestors)

Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Lora Iannotti, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2015
• First Posted: May 18, 2015
• Study Start: February 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: June 19, 2018

Record last verified: 2018-06

Locations

EC (1)