Using Stable Isotope Techniques to Monitor and Assess the Vitamin A Status of Children Susceptible to Infection in Senegal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Vitamin A status 1
研究概览
简要总结
Despite economic growth in developing countries, Sub-Saharan Africa still faces food insecurity malnutrition and infections. Micronutrient deficiency and infectious diseases still remain a public health problem and have a negative impact on health and the economy. They are both directly and indirectly responsible for children morbidity and mortality. Due to high level of children mortality (139‰) Vitamin A Supplementation (VAS) program was implemented in Senegal since 1999. A national representative study undertook in 2010 to have biological data on vitamin status and infections, showed that 24.4% of children aged 1-5 y were Vitamin A Deficiency (VAD) and 50.2% were infected. To address VAD issue, large scale oil fortification was launched by government and private industries also fortified bouillon cubes. Furthermore, home fortification is being initiated without evaluation of VAD control strategies existing in the country.
In order to assess the impact of national VAD control strategies in Senegalese children, this study was designed to measure in subsample of rural children aged 3-5 y, the current vitamin A total body stores in relation to their infectious status.
详细描述
Specifics objectives are:
Assess total body vitamin A stores and hepatic reserves before and after vitamin A supplementation in children aged 3-5 y by deuterated-retinol dilution technique Measure plasma retinol, ferritin and zinc concentrations in children Measure plasma C-reactive protein and alpha 1 glycoprotein concentrations and malaria parasitemia Identify health, socioeconomic and food determinants that can influence children micronutrient status
Study design is longitudinal with repeated measures and will be implemented in rural area. Five months after the passage of Vitamin A Supplementation (VAS) campaign, fifty children (n=50) aged 3-5y will be enrolled in the study (randomized sampling) plus 10% for drop out. The protocol will be explained to the mother and written consent will be obtained from her.
Dietary intake information will be collected using 24 hour recall questionnaire, food frequency questionnaire and infections frequency questionnaire will be submitted to the mother at d-7. Anthropometric measurements (weight and height) of children will be recorded also at d-7.
Subjects will receive doses of labeled vitamin A:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •3-5 years, not planning to move from the study area for the duration of the study, and do not have severe illness at the time of enrollment.
排除标准
- •severe anaemia, severe acute malnutrition, obesity or clinically defined severe illness, such as dehydration, severe diarrhoea or severe respiratory illness.
研究组 & 干预措施
Vitamin A supplementation
55 children will receive a Mega-dose of preformed Vitamin A as recommended by the Senegalese Ministry of Health
干预措施: Vitamin A supplementation (Dietary Supplement)
结局指标
主要结局
Vitamin A status 1
时间窗: Within the coming 2 years
Total body pool size vitamin A (mmol)
次要结局
- Acute infection(Within the coming 2 years)
- Chronic infection(Within the coming 2 years)
- Iron status(Within the coming 2 years)
- Stunting(Within the coming 2 years)
- Wasting(Within the coming 2 years)
- Underweight(Within the coming 2 years)
- Morbidity(Within the coming 2 years)
- Socioeconomic status(Within the coming 2 years)
- Dietary intake(Within the coming 2 years)
- Anemia status(Within the coming 2 years)
- Malaria parasitemia(Within the coming 2 years)