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Completed

NCT Number: NCT03345147

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

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).

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Key information

Conditions

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mixco, La Comunidad City Hall, Guatemala City, Guatemala

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About this study

The goal of this study is to assess whether VA intakes above the tolerable upper intake level (UL) and exposure to multiple programs are associated with are associated with 1) exposure to multiple VA intervention programs, and 2) elevated liver vitamin A concentration and biomarkers of excess vitamin A. Guatemala was selected as a study site because the country has a long standing national fortification program for vitamin A in sugar (law since 1975, re-launched and maintained since the 90´s). Typically, fortified sugar is used in more than 90% of households at average concentrations of 9 to 10 µg/g of sugar. VA fortified foods, in the form of fortified sugar, foods prepared with fortified sugar and other fortified foods, reach children from 2 years old to adulthood. On the other hand, high dose VA supplements, provided by local health services, only reached 10.5% of children ages 6-59 month in 2013. Children ages 2-3 and 4-5 years old with VA intakes above and below the UL will be recruited together with their mothers to assess the cumulative effect of fortification on young children and their mothers. Data from Program of Food and Nutrition Security (PROSAN), of the Ministry of Health, Guatemala in 2013, shows that coverage in the 30 Health Areas of the country is 17.9%, the lowest is 4.4% (San Marcos) and the largest 33% (Petén). Four of the 30 Region Areas correspond to the Department of Guatemala, in which urban and peri-urban areas of Guatemala City are included. In Central and North-West Guatemala Areas, coverage is 23 and 22% respectively, both above national average coverage and within the 10 out of 30 top coverages. According to PROSAN data for Micronutrient Powders in 2013, all four regions North-East, North-West, South, and Central Guatemala areas are also around or above the national coverage (14%) with 21.8, 11.2, 17.3 and 13.8% coverage. Another advantage of remaining in the 4 areas of Health around Guatemala city is that the four combined amount for 300,000 children of 0-59 month-old, that is more than 15% of the national children population reported. Even if coverages are low, population density will easier children recruitment.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children 3-5 years old and their mothers
  • Child VA intake must be above 250 micrograms/day
  • Children must be apparently healthy, Hemoglobin>9 g/dL at recruitment point, C-reactive protein<5 mg/L. For Women, Hemoglobin>10 g/dL, C-reactive protein<5 mg/L

Exclusion criteria

°Children with Congenital or chronical diseases, reported illnesses 1 week before the test. For Women: Pregnancy or lactation, Previously known Chronic Diseases

Treatment and study plan

High Vitamin A intake

Other

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).

Normal Vitamin A intake

Other

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).

Primary outcomes

  1. Total Vitamin A stores among 3-5 years-old children, in micromoles

    Time frame: 28-day study period

    Estimated using Carbon 13 (13C) 13C-retinol dilution method, by the ratio of Labelled (stable isotope) versus no labelled Vitamin A in plasma 4 days after dose of labelled VA is given.

  2. Total dietary vitamin A intake among 3-5 years-old children, in micrograms (ug)

    Time frame: 28-day study period

    Estimated using 24-hour dietary recalls, observed weigh food records, food and supplement frequency questionnaire

Secondary outcomes

  1. Plasma retinol among 3-5 years-old children

    Time frame: 28-day study period

    Estimated by High Performance Liquid Chromatography (HPLC)

  2. Plasma retinol binding protein among 3-5 years-old children

    Time frame: 28-day study period

    Estimated by ELISA

  3. Plasma Transthyretin among 3-5 years-old children

    Time frame: 28-day study period

    Estimated by immunometric automated assay

  4. Bone Health markers among 3-5 years-old children

    Time frame: 28-day study period

    Estimated by different techniques

  5. Liver function markers among 3-5 years-old children

    Time frame: 28-day study period

    Estimated by different techniques

  6. Plasma retinol among women

    Time frame: 28-day study period

    Estimated by HPLC

  7. Plasma retinol binding protein among women

    Time frame: 28-day study period

    Estimated by ELISA

  8. Plasma Transthyretin among women

    Time frame: 28-day study period

    Estimated by immunometric automated assay

  9. Total dietary vitamin A intake among women, in micrograms (ug)

    Time frame: 28-day study period

    Estimated using 24-hour dietary recalls, observed weigh food records, food and supplement frequency questionnaire

Other outcomes

  1. Hemoglobin concentration in children

    Time frame: At recruitment

    Measured with Quik Read Pro portable Device

  2. Children weight and length

    Time frame: At recruitment

    Measured with Scale and Measurement Rod

  3. Systemic inflammation in children

    Time frame: At recruitment

    Measured with Quik Read Pro portable Device

  4. Iron status in children

    Time frame: 28-day study period

    Estimated by different techniques

  5. Zinc status in children

    Time frame: 28-day study period

    Estimated by atomic emission spectrometry

Sponsors and collaborators

Lead sponsor

Institute of Nutrition of Central America and Panama

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • International Atomic Energy Agency
  • Newcastle University

Registry information

Official study title

LOAEL/NOAEL and UL Determination in Guatemala - Estimation of Vitamin A Stores in Children and Women and Correlation With Potential Toxicity Markers

Acronym: GloVitAS-GU

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 17, 2017
Registry last updated
Nov 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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