跳至主要内容
临床试验/NCT03383744
NCT03383744已完成不适用

Using Stable Isotope Techniques to Monitor and Assess the Vitamin A Status of Children Susceptible to Infection

Centre for Food and Nutrition Research, Yaounde0 个研究点目标入组 104 人开始时间: 2015年10月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
104
主要终点
Change in vitamin A status at one month

研究概览

简要总结

This is a study to evaluate the effects of vitamin A supplementation program on the vitamin A status of preschool children. All children aged 3-5 years who do not have severe illness and are not planning to move from the study area are eligible. Children whose caregivers agree to sign the consent form will be enrolled in their community and submitted to a longitudinal evaluation of vitamin A status before and after vitamin A supplementation campaign.

Vitamin A status will be assessed by measuring serum retinol, retinol binding protein and vitamin A total body pool size using stable isotope dilution methodology.

详细描述

Five months after the last supplementation (day 0), an oral dose (2 mg retinol equivalents) of label vitamin A ([2H8]-retinyl acetate) in oil will be administered to 80 eligible children together with a low vitamin A high-fat snack. Fasting venous blood samples (about 7 ml) will be collected into evacuated foil-wrapped blood collection tubes specifically designed for the collection of serum (containing no anticoagulant and metal free) on the mornings of days 0 before the administration of the dose and on day 14 for quantitative estimation of initial vitamin A pool size and determination of potential confounding parameters (CRP, AGP, iron, zinc, malaria, carotenoids and retinoids). About six months after the last supplementation (day 30), each child will received the vitamin A supplement. After 30 days and 90 days, two groups of 40 children (Grp1, Grp2) will respectively received a second dose of labeled vitamin A ([2H4]-retinyl acetate); fasting venous blood samples will be obtained before the administration of the dose and 14 days after dosing for quantitative estimation of final vitamin A pool size and determination of potential confounding parameters.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
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

入选标准

  • Children will be included if they are in the target age range (36-59 months), are not planning to move from the study area for the duration of the study and do not have severe illness at the time of enrolment

排除标准

  • Exclusion criteria will generally include the following conditions: severe anaemia, severe acute malnutrition, obesity, or clinically defined severe illness, such as dehydration, severe diarrhoea, malaria or severe respiratory illness

研究组 & 干预措施

Vitamin A supplementation 1

Experimental

Vitamin A status assessed at Baseline and one month after the administration of 200,000 IU of vitamin A

干预措施: vitamin A supplementation (Dietary Supplement)

Vitamin A supplementation 3

Experimental

Vitamin A status assessed at Baseline and three months after the administration of 200,000 IU of vitamin A

干预措施: vitamin A supplementation (Dietary Supplement)

结局指标

主要结局

Change in vitamin A status at one month

时间窗: One month after vitamin A supplementation

Change from Baseline vitamin A total body stores at one month

Change in vitamin A status at 3 months

时间窗: 3 months after vitamin A supplementation

Change from Baseline vitamin A total body stores at 3 months

次要结局

未报告次要终点

研究者

发起方
Centre for Food and Nutrition Research, Yaounde
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Medoua Nama Gabriel

Head of Centre

Centre for Food and Nutrition Research, Yaounde

相似试验

Using Stable Isotopes to Assess the Effectiveness of... | 临床试验