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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Vitamin A Status

Intervention / Treatment
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* Other: High VA intake, recent VAS
* Other: High VA intake
* Other: Low/adequate VA intake


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children 12-18 months of age, and their mothers (18-49 years of age) Living in selected communities in the National Capital Region of the Philippines The mother and child must plan to stay in the study area for the duration of the study. Child's estimated vitamin A intake and exposure to vitamin A programs must meet eligibility criteria for one of three groups, based on a screening questionnaire administered by an interviewer to the child's mother. 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: The child did not receive a high-dose VA capsule during the most recent national campaign The mother or child has chronic disease The child has moderate or severe anemia (Hb <10 g/dL) The mother or child has signs or symptoms of vitamin A deficiency (Bitot's spots, conjunctival xerosis, nightblindness) The child has weight for length < -2 z-scores of the median of the WHO growth standards The mother is breastfeeding more than one child

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1: High VA intake, recent VAS<br>Children who are exposed to multiple vitamin A (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, recent VAS<br>* 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.<br>|
| Group 2: High VA intake<br>Children who are exposed to multiple vitamin A (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: High VA intake<br>* 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.<br>|
| Group 3: Low/adequate VA intake<br>Children who are not exposed to multiple vitamin A (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. | Other: Low/adequate VA intake<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total body vitamin A stores among children 12-18 mo of age | Estimated using the 13C-retinol dilution method | 28-day study period | 
| Total dietary vitamin A intake among children 12-18 mo of age | 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) | 28-day study period | 
| Total breast milk intake (among breastfeeding children 12-18 mo of age) | Estimating using the dose-to-mother deuterium dilution technique. | 15-day study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma or serum retinol among children 12-18 mo of age |  | 28-day study period | 
| Plasma or serum retinol-binding protein among children 12-18 mo of age |  | 28-day study period | 
| Ratio of retinol to retinol-binding protein among children 12-18 mo of age |  | 28-day study period | 
| Retinol metabolites among children 12-18 mo of age |  | 28-day study period | 
| Transthyretin among children 12-18 mo of age |  | 28-day study period | 
| Bone health markers among children 12-18 mo of age |  | 28-day study period | 
| Liver function markers among children 12-18 mo of age |  | 28-day study period | 
| Consumption of fortifiable foods among women | Estimated by combining data from 24-hour recalls, observed weighed food records, food frequency questionnaires, and the Fortification Assessment Coverage Tool | 28 day study period | 
| Consumption of fortifiable foods among children | Estimated by combining data from 24-hour recalls, observed weighed food records, food frequency questionnaires, and the Fortification Assessment Coverage Tool | 28 day study period | 
| Total vitamin A intake among women | Estimated using 24-hour dietary recalls and food frequency questionnaires | 28-day study period | 
| Breast milk vitamin A concentration among lactating women |  | 28-day study period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin A status, infant, dietary assessment, retinol isotope dilution, breast milk intake