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临床试验/NCT03450174
NCT03450174Unknown不适用

Effectiveness of Multiple Micro-nutrient Fortified Fudge on Nutritional Status of 3-5 Years of Age Children: A Randomize Control Trial

University of Veterinary and Animal Sciences, Lahore - Pakistan2 个研究点 分布在 1 个国家目标入组 480 人开始时间: 2017年10月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
480
试验地点
2
主要终点
To access the improvement in children Vitamin A status

研究概览

简要总结

Multiple micro-nutrient deficiencies in Pakistan is wide spread, there is dire need to address these by using smart solutions, among them multiple fortified product (fudge) is an alternate possible way to address this issue. Fortified products have the potential to reduce micronutrient deficiencies in children, therefore in current study children from 3-5 years will receive fortified product along with enhance nutrition promotional information to bring change in their dietary practices and nutritional indices.

详细描述

As per the National Nutrition Survey, 2011 anaemia (iron deficiency) affected the children severely as one in three children under the age of 5 anemic, whereas prevalence of vitamin A deficiency among children under 5 years is more than 50%, similarly Zinc deficiency children and vitamin D deficiency prevalence in children is more than 40%.

The numerous indicators of nutrition deficiencies are related to inadequately nutritious and safe food, illiteracy, malpractices along with lack of nutritional knowledge and other social and behavioral issues. A healthy and supportive nutritional status, direct toward better intellect and earning of individual, which boost the social impact and macro level change.

Childhood stunting and deficiencies in iron and iodine hamper cognitive development, school achievement and adult productivity by 2.5-19.8 percent subsequently adult anemia reduces work performance in manual labor in the agriculture area and overall resultant US$ 7.6 billion annually loss for Pakistan, which corresponds to nearly 3 percent of GDP all due to poor nutritional indicators, which are preventable. Therefore, in developing countries like Pakistan, robust need is required, to do evidence base and translational research which could be easily converted into action that improves nutritional status.

Food fortification with micro-nutrients is effective, cost-efficient and medium-term approach to improve micro-nutrient status of vulnerable groups and is sustainable once established to prevent these at cheaper cost. There is need to investigate the positive effects of multiple micronutrient administration on child development along with there is dire need for more research to investigate it comprehensively at community level.

Fortified food products such as (milk, wheat, rice, oil, and other) are already in existing strategies worldwide to prevent micro-nutrient deficiencies in society which is well established and currently there are several extensive activities are implemented to prevent these hidden hunger but required results are not achieved.

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
Double (Participant, Care Provider)

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

  • 3-5 years of age
  • no medical complication
  • from middle-income group within the semi-urban population

排除标准

  • illness/ infections (TB, Malarial drug)
  • non-attendant
  • severe anemia/micro nutrient deficiency
  • thyroid disease
  • medication/supplementation
  • not willing to participate

研究组 & 干预措施

Control

Placebo Comparator

this group, only placebo product will be given

干预措施: Placebo (Dietary Supplement)

Formative messages

Experimental

this group will be received only daily formative messages on diet diversity, healthy and best nutrition practices

干预措施: Formative messgaes (Behavioral)

Fortified product

Experimental

this group will be received only fortified product on alternate day up to 6 months

干预措施: Fortified product (Dietary Supplement)

Fortified product plus

Experimental

this group will receive fortified product along with daily messages on diet diversity and healthy nutrition practices

干预措施: Fortified product plus (Combination Product)

结局指标

主要结局

To access the improvement in children Vitamin A status

时间窗: Will be accessed at Base-line (at start), Mid-line (after 4 months) and End-line (8 months)

Change in Serum retinol binding protein

To access the improvement in children Zinc status

时间窗: Will be accessed at Base-line (at start), Mid-line (after 4 months) and End-line (8 months)

Change in serum zinc

To access the improvement in child Iron deficiency anemia

时间窗: Will be accessed at Base-line (at start), Mid-line (after 4 months) and End-line (8 months)

change in serum Hemoglobin, serum ferritin and serum transferrin receptors

次要结局

  • Difference in the children anthropocentric status(Base-line (at start, 0 month), Mid-line (after 4 months) and End-line (8 months at start))
  • Effect on the household food security(Base-line (at start, 0 month), Mid-line (after 4 months) and End-line (8 months at start))
  • Enhancement in the early childhood development indicators(Base-line (at start, 0 month), Mid-line (after 4 months) and End-line (8 months at start))

研究者

发起方
University of Veterinary and Animal Sciences, Lahore - Pakistan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fakhar Gulzar

PhD Scholar

University of Veterinary and Animal Sciences, Lahore - Pakistan

研究点 (2)

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