Kinetics of Retinol and Total Body Stores Among Lactating Senegalese Women Living in an Urban Setting and the Relationship Between Their Total Body Stores and Those of Their Infants
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Vitamin A status
研究概览
简要总结
Vitamin A deficiency (VAD) is still a serious public health problem in most developing countries. Several strategies are used to prevent and address the consequences of this deficiency and to reduce its prevalence, particularly in Africa. In Senegal, the prevalence of VAD, although low among women of reproductive age, is quite worrying among children under 5 years old. In 2009, the fortification of refined oil with vitamin A was made mandatory in addition to the strategies already in place. The study of the impact of these strategies on the vitamin A status of women and children, showed relatively stable prevalences between 2010 and 2018. However, this study used plasma retinol concentration as an indicator. It is known that evaluation of vitamin A status is relatively insensitive when based on changes in plasma retinol concentrations, which are homeostatically controlled and negatively affected by subclinical infections. Incremental studies in the Dakar region using the modified relative dose response (MRDR) test in children under 2 years of age have indicated adequate vitamin A stores and a low prevalence of vitamin A deficiency in these children. The various strategies to prevent and control vitamin A deficiency have reportedly improved and even increased vitamin A stores in women and children, particularly in the Dakar region. Indeed, the latter benefit from substantial intakes of preformed retinol through the fortification program, and the majority of children under 2 years of age are breastfed.
The aim of this study is to use a more sensitive method than plasma retinol, the retinol isotope dilution (RID) test, to assess the actual status of subjects following these different strategies and to better orient the policies implemented in Senegal.
详细描述
Specifics objectives are:
To determine transfer of tracer to breast milk To determine the composite coefficient (FaS) using mathematical modeling To estimate TBS using the generated coefficients and the RID equation among mothers To estimate TBS from breast milk retinol using the mass balance equation among mothers To estimate TBS from serum retinol using the mass balance equation among mothers and their children To assess the agreement between TBS measured by different methods (the RID equation, the mass balance equation using serum or breast-milk derived retinol) among mothers To evaluate the relationship between mothers' and children's TBS according to their status To assess dietary intakes of vitamin A among mother-child pairs
The study is designed following a "Wonder women model". It will be implemented in Dakar city. A total of fifty-six (56) lactating mother-child pairs will be included in the study. The women will be divided into 8 groups of 7 women each. This sample size includes an attrition rate of 15%.
At baseline (day 0), blood samples will be obtained from all the women after an overnight fast. Women will also be asked to give casual milk samples. Then, each woman will be given an oral dose of 2.0 μmol 13C2 -retinyl acetate (Gannon et al., 2014; Kaliwile et al., 2021). Afterward, participants will consume a peanut butter-based snack to provide fat to improve dose absorption. The women will also have a follow-up sample taken at day 14. As for baseline, a follow-up milk sample will be collected. Short-term sampling of both blood and milk will occur between days 0 and 14 and between days 14 and 109. In total, each woman will have 4 blood and 4 milk samples taken over time.
For infants, the RID test will start at day 14. After the baseline blood, they will receive 1.0 μmol 13C2-retinyl acetate and will have a second blood sample at day 28. Thus, infants will have 2 blood samples.
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
- 9 Months 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For mothers: Willing to participate in the study and to give 4 blood and 4 milk samples during the whole duration of the study, Being aged 18-45 years, Not planning to travel during the study duration
- •For children: Being aged 9-18 months, Being breastfed, Mother willing to authorize 2 bloods, Do not receive vitamin A supplements during the study
排除标准
- •For mothers: Being pregnant, Consuming vitamin A and/or effector supplements, Smoke or drink alcohol during the study period
- •For children: Have received a vitamin A supplement in the two months prior to the study
- •All: Had fever or any obviously known or clinical diagnosed disease, malaria positive, severe anemia, severe acute malnutrition or severe obesity, being hemophiliac
结局指标
主要结局
Vitamin A status
时间窗: Within the coming 2 years
Total body store vitamin A (µmol)
次要结局
未报告次要终点