Block 37 Health Center
Mandaluyong, National Capital Region, Philippines
NCT Number: NCT03030339
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.
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Notify Me12 month–18 month
All sexes
Observational
Mandaluyong, National Capital Region, Philippines
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Eligibility criteria for children in Group 1: 1) consumed MNP or a multi-vitamin preparation that contains vitamin A in the previous 7 days, 2) consumed at least one fortified staple food (oil or wheat flour) in the previous 7 days, 3) consumed breast milk or fortified milk in the past 24 hours, 4) received a high-dose VA capsule during the previous month, and 5) received a screening tool 'score' suggesting VA intake above 600 µg retinol/d.
Eligibility criteria for children in Group 2: will include children who: 1) consumed MNP or a multi-vitamin A preparation that contains vitamin A in the previous 7 days, 2) consumed at least one fortified staple food (oil or wheat flour) in the previous 7 days, 3) consumed breast milk or fortified milk in the past 24 hours, 4) received a high-dose VA capsule in the previous 3-6 months, and 5) received a screening tool 'score' suggesting VA intake above 600 µg retinol/d.
Eligibility criteria for children in Group 3: will include children who: 1) received a high dose VA capsule during the previous 3-6 months, and 2) received a screening tool 'score' suggesting VA intake 200-500 µg/d.
Exclusion criteria
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.
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.
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.
Time frame: 28-day study period
Estimated using the 13C-retinol dilution method
Time frame: 28-day study period
Estimated using 24-hour dietary recalls, observed weighed food records, food and supplement frequency questionnaire, breast milk vitamin A concentration, and total breast milk intake (measured by the dose-to-mother deuterium dilution technique)
Time frame: 15-day study period
Estimating using the dose-to-mother deuterium dilution technique.
Time frame: 28-day study period
Time frame: 28-day study period
Time frame: 28-day study period
Time frame: 28-day study period
Time frame: 28-day study period
Time frame: 28-day study period
Time frame: 28-day study period
Time frame: 28 day study period
Estimated by combining data from 24-hour recalls, observed weighed food records, food frequency questionnaires, and the Fortification Assessment Coverage Tool
Time frame: 28 day study period
Estimated by combining data from 24-hour recalls, observed weighed food records, food frequency questionnaires, and the Fortification Assessment Coverage Tool
Time frame: 28-day study period
Estimated using 24-hour dietary recalls and food frequency questionnaires
Time frame: 28-day study period
Time frame: 28-day study period and 30 days prior to study period
Time frame: 28-day study period and 30 days prior to study period
Time frame: At recruitment
Time frame: At recruitment
Time frame: 28-day study period
Time frame: 28-day study period
Time frame: 28-day study period
Time frame: 28-day study period
Time frame: 28-day study period
Time frame: At enrollment
Time frame: 28-day study period and previous 7 days
University of California, Davis
Other
Vitamin A Status and Risk of Excessive Vitamin A Intake Among Urban Filipino Children Exposed to Multiple Vitamin A Intervention Programs
Acronym: GloVitAS-P
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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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