Vitamin A Status and Risk of Excessive Vitamin A Intake Among Urban Filipino Children Exposed to Multiple Vitamin A Intervention Programs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Total dietary vitamin A intake among children 12-18 mo of age
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Total dietary vitamin A intake among children 12-18 mo of age
时间窗: 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)
Total breast milk intake (among breastfeeding children 12-18 mo of age)
时间窗: 15-day study period
Estimating using the dose-to-mother deuterium dilution technique.
Total body vitamin A stores among children 12-18 mo of age
时间窗: 28-day study period
Estimated using the 13C-retinol dilution method
次要结局
- Liver function markers among children 12-18 mo of age(28-day study period)
- Consumption of fortifiable foods among women(28 day study period)
- Plasma or serum retinol-binding protein among children 12-18 mo of age(28-day study period)
- Total vitamin A intake among women(28-day study period)
- Transthyretin among children 12-18 mo of age(28-day study period)
- Consumption of fortifiable foods among children(28 day study period)
- Retinol metabolites among children 12-18 mo of age(28-day study period)
- Plasma or serum retinol 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)
- Bone health markers among children 12-18 mo of age(28-day study period)
- Breast milk vitamin A concentration among lactating women(28-day study period)