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.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 771
- 试验地点
- 2
- 主要终点
- Haemotological parameters (haemoglobin, transferrin saturation, and ferritin)
研究概览
简要总结
The objective of the program is to examine the efficacy of 6 month home micronutrient supplementation in Bedouin and Jewish children on improvements in nutritional status including measures of iron, ferritin, zinc and folic acid, and measures of growth and health parameters i.e.reported and recorded morbidity.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 5 Months 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Haemotological parameters (haemoglobin, transferrin saturation, and ferritin)
时间窗: 12, 18 and 24 months
Micronutrient status (Iron, Zinc and B12 and Folic acid level)
时间窗: 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)
时间窗: 12, 18, 24 months
Health Care Services use (primary care clinics visits, emergency room visits, hospitalizations
时间窗: 24 months
次要结局
- Reported morbidity due to infectious diseases (lower respiratory tract infections, diarrhea, sepsis, otitis media, cutaneous infections, fever)(12, 18, 24 months)
- Growth parameters (WAZ, HAZ, WHZ)(12, 18, 24 months)
- Safety, diarrhea, constipation, color, smell and form of stool changes. Any other adverse events.(12 months)