NCT03902145

LULUN PROJECT II - Cohort Follow-up Study

Completed Last updated 3 April 2019

What this trial tests

trial testing Egg in Stunting in 270 participants. Completed in 31 August 2017.

Timeline

1 June 2017

Primary endpoint
31 August 2017

31 August 2017

Quick facts

Lead sponsor	Washington University School of Medicine
Status	Completed
Study type	OBSERVATIONAL
Enrollment	270
Start date	1 June 2017
Primary completion	31 August 2017
Estimated completion	31 August 2017
Sites	1 location across Ecuador

Drugs / interventions tested

• Egg

Conditions studied

• Stunting — all drugs for Stunting →

Sponsor

Washington University School of Medicine

Who can join

Adults 30 Months to 36 Months, any sex, with Stunting. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Ultra-processed foods in a rural Ecuadorian community: associations with child anthropometry and bone maturation.
   Gyimah EA, Nicholas JL, Waters WF, Gallegos-Riofrío CA, et al · · 2023 · cited 3× · PMID 36912073 · DOI 10.1017/s0007114523000624