LULUN PROJECT II - Cohort Follow-up Study

NCT03902145 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 270

Last updated 2019-04-03

No results posted yet for this study

Summary

Child stunting and micronutrient deficiencies are a major problem in developing countries, affecting millions of children.

Beginning at 6 months children need foods to complement nutrients received through breastfeeding; however, complementary feeding diets are well-documented to be inadequate in the developing world. Eggs, which are widely available and low-cost relative to other highly nutritious foods are underutilized and could potentially improve child growth and development. Prior to the Lulun Project RCT, no research had been conducted to evaluate their efficacy in improving micronutrient status. Lulun filled an important gap in the literature by examining, through a randomized controlled trial, the effect of egg consumption on biochemical markers of choline, vitamin B12, lipids, and amino acids in young children in a poor rural area of Ecuador. However, there is still scarce data on how early child complementary feeding interventions, such as the Lulun egg intervention, might impact child growth long-term.

This study will be designed as a follow-up cohort study to the Lulun Project RCT conducted in Cotopaxi Province from March-December 2015. The proposed follow-up study will investigate the potential long-term impacts of the egg intervention on child growth. Children and mother (caregiver) dyads with endline anthropometric measures from Lulun Project will be invited to participate in the follow-up study. Data will be collected on demographic, socioeconomic, and environmental information, morbidities, and child diet (including egg preparation and consumption), as well as child anthropometry (height, weight, head circumference). Additionally, the study will pilot test and compare radiographic measures of child bone maturity and organ size (kidney, liver, and spleen) using an app-based ultrasound. Investigators from Universidad de San Franscisco de Quito (USFQ), Washington University in St. Louis, and Mathile Institute will collaborate to conduct the study.

This project will also include a gender assessment component designed to ascertain how gender norms may affect prospects for successful scale up of smallholder poultry production. To this end, qualitative data will be collected from a small sample of participating mothers (caregivers) and key community stakeholders, in the form of in-depth interviews and/or focus groups.

Conditions

  • Stunting

Interventions

OTHER

Egg

One egg per day for 6 months

Sponsors & Collaborators

  • The Mathile Institute for the Advancement of Human Nutrition

    collaborator OTHER
  • Universidad San Francisco de Quito

    collaborator OTHER
  • University of California, Davis

    collaborator OTHER
  • RTI International

    collaborator OTHER
  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Lora Iannotti, PhD · Washington University School of Medicine

Eligibility

Min Age
30 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-01
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • Ecuador

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03902145 on ClinicalTrials.gov