NCT03030339

Vitamin A Status and Risk of Excessive Vitamin A Intake Among Urban Filipino Children

Vitamin A Status and Risk of Excessive Vitamin A Intake Among Urban Filipino Children Exposed to Multiple Vitamin A Intervention Programs

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 123 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 12 Months – 18 Months
• Healthy volunteers: Not accepted

Summary

The goal of this study is to assess whether children 12-18 months of age who are exposed to multiple large-scale vitamin A programs, and who are likely to have vitamin A intakes above the tolerable upper intake level (UL), have higher total body vitamin A stores and biomarkers of excessive vitamin A status, compared to children 12-18 months of age who have adequate vitamin A intake.

Detailed description

This is an observational study with 3 groups, which are identified using a screening tool to obtain information on exposure to vitamin A programs and consumption of vitamin A-rich foods and supplements. Children and their mothers are studied over the course of one month to determine 1) child total body vitamin A stores, using the 13C retinol isotope dilution method, 2) the child's vitamin A intake, using multiple dietary assessment methods, 3) total breast milk intake (among breastfeeding children), using the dose-to-mother deuterium dilution method, and 4) potential biomarkers of excessive vitamin A status, including markers of bone and liver health. Blood collection is structured in a "Super-Child" design, to construct plasma retinol kinetic curves. Other indicators related to vitamin A nutrition among children will be measured, in addition to the vitamin A intake and breast milk vitamin A concentration (for breastfeeding mothers) of the mother.

Conditions

• Vitamin A Status

Interventions

Type	Name	Description
OTHER	High VA intake, recent VAS	Children who are exposed to multiple VA programs, have received a high-dose VA supplement (VAS; 200,000 IU) in the past month, and are identified as being likely to have chronic excessive dietary VA intake.
OTHER	High VA intake	Children who are exposed to multiple VA programs, have received a high-dose VA supplement (200,000 IU) in the past 3-6 months, and are identified as being likely to have chronic excessive dietary VA intake.
OTHER	Low/adequate VA intake	Children who are not exposed to multiple VA programs, have received a high-dose VA supplement in the past 3-6 months, and are identified as being likely to have chronic low to adequate dietary VA intake.

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2017-01-25
• Last updated: 2017-05-04

Locations

1 site across 1 country: Philippines