Efficacy Trial to Examine Efficacy of Multimicronutrient Home Supplementation in Infants
Controlled Clinical Trial to Assess the Effect of Multiple Micronutrient Supplementation (Iron, Vitamins A, C, D, Folic Acid and Zinc) on Nutritional and Health Indicators in Infants in Southern Israel.
研究概览
详细说明
The high level of anemia persists in Negev children despite the existence of a policy of the Ministry of Health that calls for Iron, Vitamin A and Vitamin D supplementation up to 12 months of age. In addition, other micronutrient deficiencies in this population have been described in several studies. These may be related to; low adherence with existing recommendations; need for additional micronutrients other than Iron, Vitamin A and Vitamin D; the need for a different delivery system more acceptable to mothers and infants.
We will compare in Bedouin and Jewish children separately the efficacy of daily use of Sprinkles(home Micronutrient fortification) from age 6 to 12 months in infants recruited in Maternal and Child Health clinics.
The comparison will be children recruited in clinics of comparable socioeconomic status, where current Ministry of Health recommendations (drops of iron and vitamins A plus D) are the treatment regimen.
研究类型
注册 (预期的)
阶段
- 第三阶段
联系人和位置
学习地点
-
-
-
Beer-Sheva、以色列、10050
- Ministry of Health
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Infant aged 5-7 months
- Infant whose parents give their written informed consent
- Infants whose parents intend to reside within the area for at least 12 months
- Infants receiving any additional food besides breast feeding
Exclusion Criteria:
- Known or suspected haemotological disorders
- Known or suspected anemia (Hb <11 gr/dl)
- Known or suspected immunological disorders
- Known or suspected malabsorption disorders
- Enrolled or scheduled to be enrolled in another clinical trial
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：1
Supplementation with daily sprinkle package
|
Daily dosage of fat coated iron (desote fumarate) 12.5 mg, zinc 5mg, vitamin A 300 micrograms, folic acid 150 micrograms, ascorbic acid 50 mg.
|
|
有源比较器：2
Supplementation with Iron tonic 15mg, vitamins A 300 micrograms, vitamin D 10 micrograms.
According to Ministry of Health routine recommendations.
|
Daily dosage of Iron tonic 15mg, vitamins A 300 micrograms, vitamin D 10 micrograms once a day from age 6 months up to age 12 months
其他名称：
|
|
无干预：3
No intervention except for checking outcomes at approprite times.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Haemotological parameters (haemoglobin, transferrin saturation, and ferritin)
大体时间：12, 18 and 24 months
|
12, 18 and 24 months
|
|
Micronutrient status (Iron, Zinc and B12 and Folic acid level)
大体时间：12, 18 months
|
12, 18 months
|
|
Incidence of infectious diseases total morbidity (IDTM) due to respiratory tract infections, diarrhea, sepsis, otitis media, cutaneous infections, fever) and all illnesses (ACTM)
大体时间：12, 18, 24 months
|
12, 18, 24 months
|
|
Health Care Services use (primary care clinics visits, emergency room visits, hospitalizations
大体时间：24 months
|
24 months
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Reported morbidity due to infectious diseases (lower respiratory tract infections, diarrhea, sepsis, otitis media, cutaneous infections, fever)
大体时间：12, 18, 24 months
|
12, 18, 24 months
|
|
Growth parameters (WAZ, HAZ, WHZ)
大体时间：12, 18, 24 months
|
12, 18, 24 months
|
|
Safety, diarrhea, constipation, color, smell and form of stool changes. Any other adverse events.
大体时间：12 months
|
12 months
|
合作者和调查者
调查人员
- 首席研究员：Drora Fraser, PhD、Ben-Gurion University of the Negev
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.