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| ID | Type | Description | Link |
|---|---|---|---|
| OPP1115464 | Other Grant/Funding Number | Other |
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| Name | Class |
|---|---|
| Newcastle University | OTHER |
| Penn State University | OTHER |
| Helen Keller International | OTHER |
| Food and Nutrition Research Institute, Philippines |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: High VA intake, recent VAS | 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 |
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| Group 2: High VA intake | 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. |
| |
| Group 3: Low/adequate VA intake | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High VA intake, recent VAS | Other | 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. |
| 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 |
| 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 | |
| Measure | Description | Time Frame |
|---|---|---|
| Total food and nutrient intakes among women | 28-day study period and 30 days prior to study period | |
| Total food and nutrient intakes among children | 28-day study period and 30 days prior to study period | |
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:
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Children 12-18 months of age and their mothers in selected neighborhoods in the National Capital Region of the Philippines
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| Name | Affiliation | Role |
|---|---|---|
| Georg Lietz | Newcastle University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Block 37 Health Center | Mandaluyong | National Capital Region | Philippines |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42008529 | Derived | Lietz G, Oxley A. Formulation of Vitamin A Tracer Doses for Administration to Human Subjects using Retinol Isotope Dilution Technique. J Vis Exp. 2026 Mar 31;(229). doi: 10.3791/69240. | |
| 36060221 | Derived | Engle-Stone R, Miller JC, Reario MFD, Arnold CD, Stormer A, Lafuente E, Oxley A, Capanzana MV, Cabanilla CVD, Ford JL, Clark A, Velavan TP, Brown KH, Lietz G, Haskell MJ. Filipino Children with High Usual Vitamin A Intakes and Exposure to Multiple Sources of Vitamin A Have Elevated Total Body Stores of Vitamin A But Do Not Show Clear Evidence of Vitamin A Toxicity. Curr Dev Nutr. 2022 Jul 25;6(8):nzac115. doi: 10.1093/cdn/nzac115. eCollection 2022 Aug. |
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To be determined.
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| OTHER_GOV |
| Global Alliance for Improved Nutrition | OTHER |
| Bill and Melinda Gates Foundation | OTHER |
| International Atomic Energy Agency | OTHER_GOV |
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Serum, plasma, red and white cells, dried blood spots, breast milk
| High VA intake | Other | 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. |
|
| Low/adequate VA intake | Other | 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. |
|
| 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 |
| Infant weight-for-length z score |
| At recruitment |
| Infant length-for-age z score | At recruitment |
| Systemic inflammation among children | 28-day study period |
| Iron status among children | 28-day study period |
| Zinc status among children | 28-day study period |
| Hepatitis infection among children | 28-day study period |
| Genetic markers related to vitamin A metabolism among children | 28-day study period |
| Infant hemoglobin concentration | At enrollment |
| Infant morbidity symptoms | 28-day study period and previous 7 days |
| 33755155 | Derived | Oxley A, Engle-Stone R, Miller JC, Reario MFD, Stormer A, Capanzana MV, Cabanilla CVD, Haskell MJ, Lietz G. Determination of Vitamin A Total Body Stores in Children from Dried Serum Spots: Application in a Low- and Middle-Income Country Community Setting. J Nutr. 2021 May 11;151(5):1341-1346. doi: 10.1093/jn/nxaa446. |
| 31535129 | Derived | Ford JL, Green JB, Haskell MJ, Ahmad SM, Mazariegos Cordero DI, Oxley A, Engle-Stone R, Lietz G, Green MH. Use of Model-Based Compartmental Analysis and a Super-Child Design to Study Whole-Body Retinol Kinetics and Vitamin A Total Body Stores in Children from 3 Lower-Income Countries. J Nutr. 2020 Feb 1;150(2):411-418. doi: 10.1093/jn/nxz225. |