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临床试验/NCT01484756
NCT01484756已完成3 期

Combined Vitamins and Minerals Decrease Incidence of Upper Respiratory Tract Infections in Older Persons

Trisakti University2 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2008年8月最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
270
试验地点
2
主要终点
upper respiratory infection

研究概览

简要总结

Nutrient deficiency and immune dysfunction in older persons result in high prevalence of acute respiratory infection,which can lead to impaired nutritional status. The study objective was to determine the effect of multi micro-nutrient supplementation on nutritional and upper respiratory infection among apparently healthy community-dwelling elderly. The main hypothesis was whether daily multi micro-nutrient supplementation could reduce the incidence and prevalence of upper respiratory infection among apparently healthy community-dwelling older persons. Inclusion criteria were apparently independent healthy male and female older persons aged 60 years and over, not taking multi micro-nutrient supplementation over the last month. The study design was a community-based double-blind controlled trial involving 296 community-dwelling older persons aged 60 and above, in the Mampang Prapatan district, South Jakarta. Participants were randomized to receive either 40 mg elemental zinc (as gluconate), 120 mg ascorbic acid, 6 mg B-carotene, 15 mg alpha tocopherol (as d-alpha-tocopheryl acid succinate) and 400 micrograms folic acid (intervention group) or 400 mg calcium carbonate (control group). Supplements were taken daily for six months, from August 2008 to March 2009. Nutritional and health status were measured before and after supplementation. Poisson regression analysis was used to evaluate the effects of daily multi micro-nutrient supplementation on the incidence and prevalence of upper respiratory infection.

详细描述

Poor nutritional status of older persons may predispose them to increased risk of upper respiratory tract infection, which however should be amenable to reduction by multi micro-nutrient supplementation. For becoming a successful healthy aging individual, the interrelationship between endogenous and exogenous factors must be positive and balanced. Introducing multi micro-nutrients through supplementation is an alternative which ensures a balanced micro-nutrient intake for enhancing the immune response and at the same time possibly enhancing the quality of life of the healthy free-living elderly individual.

The role of nutritional intervention strategies have been shown to be beneficial in the prevention of infectious disease among the older population in order to reduce the burden of diseases, and also could prevent micro-nutrient deficiency and enhance immune response of older persons.

The present study is related to primary prevention activities which aim to enhance the health status of the subjects, in particular to reduce the incidence and prevalence rate of infectious diseases, especially of upper respiratory tract infection. Supplementation is operationally achievable for implementation at the health center and could be set within the existing programs for older persons.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • women and men aged 60 years and above
  • apparently healthy
  • independent
  • not taking supplementation during the last month

排除标准

  • dementia or uncontrolled hypertension
  • physically handicapped
  • post cataract extraction

研究组 & 干预措施

daily multi micronutrient supplement

Experimental

Experimental group received one daily multi micro-nutrient supplement tablet for 6 months

干预措施: daily multi micronutrient supplement (Dietary Supplement)

calcium carbonate 500 mg

Placebo Comparator

Control group received one daily tablet of calcium carbonate 500 mg for 6 months

干预措施: Placebo (Dietary Supplement)

结局指标

主要结局

upper respiratory infection

时间窗: 6 months

This study measures number of new episodes of upper respiratory infection per total days of observation

次要结局

  • upper respiratory infection(6 months)

研究者

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

Rina K Kusumaratna

Combined vitamins and minerals decrease incidence of upper respiratory tract infections in older persons

Trisakti University

研究点 (2)

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