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Liver and Bone Retinol Levels in Guatemalan Adolescents and Adults

NCT04438200 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2020-06-18

No results posted yet for this study

Summary

Guatemala has enforced mandatory fortification of sugar with vitamin A (VA) since June 1974 and has led to a highly successful reduction in VA deficiency and associated disease. However, Ribaya-Mercado et al. 2014, estimated the biological impact of sugar fortified with retinyl palmitate that there may be a risk of chronic excess intake of preformed VA associated with programs of mass fortification. A recent food consumption survey in two departments in Guatemala found the average daily sugar intake in children under the age of two who aren´t being breastfed is 30.3 g, which translates into a daily intake of 272 μg of retinol (almost the full estimated average requirement (EAR) for that age group). Since data from the second National Survey on Micronutrients suggest a risk of VA toxicity, it is important to determine the levels of hepatic VA directly in corpses of individuals, of all ages, who have died of non-metabolic causes. Due to this, the investigators propose to assess liver and bone VA levels in combination with gene expression, histopathology and biochemical analyses, to elicit indications of hypervitaminosis A in Guatemala.

Conditions

  • Vitamin A Deficiency
  • Vitamin A Toxicity
  • Hypervitaminosis A

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • HarvestPlus

    collaborator OTHER

  • Institute of Nutrition of Central America and Panama

    collaborator OTHER

  • INACIF

    collaborator UNKNOWN

  • Newcastle University

    lead OTHER

Principal Investigators

  • Francisco Chew, MD · Institute of Nutrition of Central America and Panama

  • Erick Boy, MD, PhD · HarvestPlus

  • Georg Lietz, PhD · Newcastle University

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-24
Primary Completion
2020-07-31
Completion
2020-07-31

Countries

  • Guatemala
  • United Kingdom

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 NCT04438200 on ClinicalTrials.gov