GloVitAS-GU: Estimation of Vitamin A Stores in Children and Women in Guatemala and Relation With Potential Toxicity Markers
Study Details
Study Description
Brief 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Normal Vitamin A intake Normal Vitamin A intake will be assessed by a questionnaire directed to the consumption of food items with high VA content on the 7 days prior to the questionnaire. The daily consumption will be assessed on average. A child is assigned to Normal Vit. A consumption if daily Vit. A is between 250 and 600 micrograms per day. |
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).
|
| High Vitamin A intake High Vitamin A intake will be assessed by a questionnaire directed to the consumption of food items with high VA content on the 7 days prior to the questionnaire. The daily consumption will be assessed on average. A child is assigned to High Vit. A consumption if daily Vit. A is above 900 micrograms per day. |
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).
|
Outcome Measures
Primary Outcome Measures
- Total Vitamin A stores among 3-5 years-old children, in micromoles [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.
- Total dietary vitamin A intake among 3-5 years-old children, in micrograms (ug) [28-day study period]
Estimated using 24-hour dietary recalls, observed weigh food records, food and supplement frequency questionnaire
Secondary Outcome Measures
- Plasma retinol among 3-5 years-old children [28-day study period]
Estimated by High Performance Liquid Chromatography (HPLC)
- Plasma retinol binding protein among 3-5 years-old children [28-day study period]
Estimated by ELISA
- Plasma Transthyretin among 3-5 years-old children [28-day study period]
Estimated by immunometric automated assay
- Bone Health markers among 3-5 years-old children [28-day study period]
Estimated by different techniques
- Liver function markers among 3-5 years-old children [28-day study period]
Estimated by different techniques
- Plasma retinol among women [28-day study period]
Estimated by HPLC
- Plasma retinol binding protein among women [28-day study period]
Estimated by ELISA
- Plasma Transthyretin among women [28-day study period]
Estimated by immunometric automated assay
- Total dietary vitamin A intake among women, in micrograms (ug) [28-day study period]
Estimated using 24-hour dietary recalls, observed weigh food records, food and supplement frequency questionnaire
Other Outcome Measures
- Hemoglobin concentration in children [At recruitment]
Measured with Quik Read Pro portable Device
- Children weight and length [At recruitment]
Measured with Scale and Measurement Rod
- Systemic inflammation in children [At recruitment]
Measured with Quik Read Pro portable Device
- Iron status in children [28-day study period]
Estimated by different techniques
- Zinc status in children [28-day study period]
Estimated by atomic emission spectrometry
Eligibility Criteria
Criteria
Inclusion Criteria:
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Children 3-5 years old and their mothers
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Child VA intake must be above 250 micrograms/day
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mixco, La Comunidad City Hall | Guatemala City | Guatemala | ||
| 2 | Santa Catarina Pinula City Hall | Guatemala City | Guatemala | ||
| 3 | Sacatepequez City Hall | Guatemala | Guatemala |
Sponsors and Collaborators
- Institute of Nutrition of Central America and Panama
- Newcastle University
- Bill and Melinda Gates Foundation
- International Atomic Energy Agency
Investigators
- Principal Investigator: Dora I Mazariegos, MsSc, Institute of Nutrition of Central America and Panama
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIE-REV 061/2016