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

Vitamin A Status Clinical Trial

— GloVitAS-GU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03345147
• Other study ID #: CIE-REV 061/2016
• Status: Completed
• Phase: N/A
• First received: August 25, 2017
• Last updated: November 13, 2017
• Start date: January 13, 2017
• Est. completion date: October 30, 2017

Study information

• Verified date: November 2017
• Source: Institute of Nutrition of Central America and Panama
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: October 30, 2017
• Est. primary completion date: September 13, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Vitamin A Status

Intervention

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).
• 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).

Locations

Country	Name	City	State
Guatemala	Sacatepequez City Hall	Guatemala
Guatemala	Mixco, La Comunidad City Hall	Guatemala City
Guatemala	Santa Catarina Pinula City Hall	Guatemala City

Sponsors (4)

Lead Sponsor	Collaborator
Institute of Nutrition of Central America and Panama	Bill and Melinda Gates Foundation, International Atomic Energy Agency, Newcastle University

Country where clinical trial is conducted

Guatemala, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hemoglobin concentration in children	Measured with Quik Read Pro portable Device	At recruitment
Other	Children weight and length	Measured with Scale and Measurement Rod	At recruitment
Other	Systemic inflammation in children	Measured with Quik Read Pro portable Device	At recruitment
Other	Iron status in children	Estimated by different techniques	28-day study period
Other	Zinc status in children	Estimated by atomic emission spectrometry	28-day study period
Primary	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.	28-day study period
Primary	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	28-day study period
Secondary	Plasma retinol among 3-5 years-old children	Estimated by High Performance Liquid Chromatography (HPLC)	28-day study period
Secondary	Plasma retinol binding protein among 3-5 years-old children	Estimated by ELISA	28-day study period
Secondary	Plasma Transthyretin among 3-5 years-old children	Estimated by immunometric automated assay	28-day study period
Secondary	Bone Health markers among 3-5 years-old children	Estimated by different techniques	28-day study period
Secondary	Liver function markers among 3-5 years-old children	Estimated by different techniques	28-day study period
Secondary	Plasma retinol among women	Estimated by HPLC	28-day study period
Secondary	Plasma retinol binding protein among women	Estimated by ELISA	28-day study period
Secondary	Plasma Transthyretin among women	Estimated by immunometric automated assay	28-day study period
Secondary	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	28-day study period