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Estimation of Vitamin A Stores in Children and Women in Guatemala and Relation With Potential Toxicity Markers

NCT03345147 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 178

Last updated 2017-11-17

No results posted yet for this study

Summary

The goal of this study is to assess whether 3-5 years-old children who have Vitamin A intakes above the tolerable upper intake level (UL=900 ug per day) have higher total body Vitamin A stores and biomarkers of excessive vitamin A status, compared to children with Normal Vitamin A intakes (250-600 ug per day).

Conditions

  • Vitamin A Status

Interventions

OTHER

High Vitamin A intake

Total Vitamin A stores will be assessed by isotopic measurement, 13C-Retinol will be given to the subject and blood wil be drawn on Day 4 to assess the isotopic dilution in the plasma. Other biochemical indicators will be assessed too, along with Dietary assessment (Food Frequency, 24 hours recalls).

OTHER

Normal Vitamin A intake

Total Vitamin A stores will be assessed by isotopic measurement, 13C-Retinol will be given to the subject and blood wil be drawn on Day 4 to assess the isotopic dilution in the plasma. Other biochemical indicators will be assessed too, along with Dietary assessment (Food Frequency, 24 hours recalls).

Sponsors & Collaborators

  • Newcastle University

    collaborator OTHER

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • International Atomic Energy Agency

    collaborator OTHER_GOV

  • Institute of Nutrition of Central America and Panama

    lead OTHER

Principal Investigators

  • Dora I Mazariegos, MsSc · Institute of Nutrition of Central America and Panama

Eligibility

Min Age
3 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-13
Primary Completion
2017-09-13
Completion
2017-10-30

Countries

  • Guatemala

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 NCT03345147 on ClinicalTrials.gov