跳至主要内容
临床试验/NCT01198574
NCT01198574已完成3 期

The Role of Sub-clinical Inflammation on the Iron Status of Myanmar Anaemic Adolescent Schoolgirls During Iron and Vitamin A Supplementation

Indonesia University1 个研究点 分布在 1 个国家目标入组 402 人开始时间: 2010年7月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
402
试验地点
1
主要终点
Haemoglobin Level

研究概览

简要总结

Anemia and vitamin A deficiency (VAD) are major nutritional problems in the world and also in Myanmar. Both nutrient deficiencies result from interaction of several causal factors, and a better understanding of the etiology to interpret the prevalence and to formulate appropriate measures to reduce these deficiencies is necessary. There is a growing concern on the role of sub-clinical inflammation on the nutritional status indicators during the nutritional status assessment. However, there is lack of information on the role of inflammation on the iron supplementation. The adolescent period is a window of opportunity to improve the preconceptional iron status of the girls and recently gained much attention. The purpose of the study is to understand the role of inflammation on iron and vitamin A status during iron and vitamin A supplementation. The findings will show the extent to which iron supplementation has been hampered by inflammation and to formulate the necessary measures to overcome the interference.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
12 Years 至 19 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • adolescent girls (age 12-19 years)
  • already experienced menarche
  • anemic girls (Hb<120 g/L)
  • no known illness (apparently healthy)
  • free from haemoglobinopathy
  • No regular consumption of iron and vitamin A supplement during the last 3 months

排除标准

  • subjects with chronic illness
  • subjects with severe anaemia
  • who do not give the consents

结局指标

主要结局

Haemoglobin Level

时间窗: at week 0, week 6 and week12

Haemoglobin level (g/L) measured by cyanmethaemoglobin method

Status of Tissue Iron Store

时间窗: at week 0, week 6 and week12

Tissue iron store was measured by serum ferritin

Status of Cellular Iron Deficiency

时间窗: at week 0, week 6 and week12

Cellular Iron deficiency status is also measured by serum transferrin receptor

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Min Kyaw Htet

Dr

Indonesia University

研究点 (1)

Loading locations...

相似试验