NCT02446873|Completed
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Sponsor study identifier
interventional
171
1 country
1
Study Start
February 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2017
Actual (reported)Study Completion
February 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2015
Date type not reportedThis date has not been verified as actual or estimated.
February 28, 2015
Actual (reported)May 18, 2015
Actual (reported)February 2017
Actual (reported)February 2017
Actual (reported)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
Attitudes, beliefs, and use of eggs in Pastocalle during the complementary feeding period.
6 months
Control group
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Pastocalle Parish
Pastocalle, Cotopaxi Province, Ecuador
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Charmaz, K, 2000, 'Grounded theory: Objectivist and constructivist methods' in Handbook of qualitative research (2nd Edition).
Charmaz, K, 2006, Constructing grounded theory: A practical guide through qualitative analysis.
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.
Lora Iannotti, PhD
Washington University School of Medicine
171 participants (actual enrollment reported by the registry).
First Submitted
February 28, 2015
First Posted
May 18, 2015
Study Start
February 2015
Date type not reportedThis date has not been verified as actual or estimated.
Relative Bioavailability of Folic Acid and L-5-Methlytetrahydrofolate
Frequency of consumption of eggs, other animal source foods, and dietary diversity more broadly in the child's diet in Pastocalle.
6 months
Contact the study team to confirm eligibility.
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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.
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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.
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.
Primary Completion
February 2017
Actual (reported)Study Completion
February 2017
Actual (reported)Last Updated
June 19, 2018
Record last verified: 2018-06
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