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).
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.
Study Type
OBSERVATIONAL
Enrollment
178
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).
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).
Mixco, La Comunidad City Hall
Guatemala City, Guatemala
Sacatepequez City Hall
Guatemala City, Guatemala
Santa Catarina Pinula City Hall
Guatemala City, Guatemala
Total Vitamin A stores among 3-5 years-old children, in micromoles
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.
Time frame: 28-day study period
Total dietary vitamin A intake among 3-5 years-old children, in micrograms (ug)
Estimated using 24-hour dietary recalls, observed weigh food records, food and supplement frequency questionnaire
Time frame: 28-day study period
Plasma retinol among 3-5 years-old children
Estimated by High Performance Liquid Chromatography (HPLC)
Time frame: 28-day study period
Plasma retinol binding protein among 3-5 years-old children
Estimated by ELISA
Time frame: 28-day study period
Plasma Transthyretin among 3-5 years-old children
Estimated by immunometric automated assay
Time frame: 28-day study period
Bone Health markers among 3-5 years-old children
Estimated by different techniques
Time frame: 28-day study period
Liver function markers among 3-5 years-old children
Estimated by different techniques
Time frame: 28-day study period
Plasma retinol among women
Estimated by HPLC
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Time frame: 28-day study period
Plasma retinol binding protein among women
Estimated by ELISA
Time frame: 28-day study period
Plasma Transthyretin among women
Estimated by immunometric automated assay
Time frame: 28-day study period
Total dietary vitamin A intake among women, in micrograms (ug)
Estimated using 24-hour dietary recalls, observed weigh food records, food and supplement frequency questionnaire
Time frame: 28-day study period