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临床试验/NCT01971112
NCT01971112Unknown不适用

Effect of Supplementation With Multivitamins and Minerals on the Incidence of Respiratory Infections in Older People in Ecuador: a Randomised Controlled Trial.

Corporacion Ecuatoriana de Biotecnologia1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2013年10月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
320
试验地点
1
主要终点
Incidence of respiratory infections (upper plus lower)

研究概览

简要总结

Poor Ecuadorian older people suffer from chronic dietary deficiencies of zinc, iron, copper, vitamins C, B6, B12, D, and folic acid. The investigators have previously shown that these deficiencies are associated with impaired immune function and increased incidence of respiratory infections (RI). The hypothesis is that correction of these specific nutrient deficiencies will improve immune response and thereby enhance resistance to respiratory infections. To test this hypothesis this study will evaluate the effect of supplementation with specific vitamins and minerals found to be deficient in poor elderly Ecuadorians on markers of immune function and the incidence of RI. A randomized, double-blind, placebo-controlled trial in 320 older people (≥65 y)will be carried out in Quito, Ecuador. Participants will receive multivitamin and mineral supplements or placebo tablets daily for 12 months. Nutrients will be provided at US Recommended Daily Allowance (RDA) levels, except for vitamin C and zinc doses, which will be 5 times and 1.25 times higher than the RDA, respectively. Incidence of respiratory infections (the primary outcome) will be assessed weekly by field nurses and physicians from the study team. Secondary outcomes include delayed-type hypersensitivity (DTH) skin test, cathelicidin production by mucosa respiratory cells, and serum C-reactive protein (CRP) as measures of immune function. Blood micronutrient levels and haemoglobin status will be collected as measures of adherence to the trial regimen. Incidence rate of RI and rate ratio (RR) will be calculated to quantify the effect of the intervention on the incidence of respiratory infection. This will be the first trial of its kind conducted specifically in a population of older people known to have poor micronutrient status. The findings of the study may be important for similar populations in other low- and middle-income countries.

详细描述

Even "subtle subclinical deficiencies of micronutrients and inadequate macronutrient intake contribute to a decline in immune function in the elderly" [1]. "The impaired regulation of the immune system in aging contributes to a higher morbidity and mortality from infections, autoimmune, and neoplastic diseases"[1]. Some studies show that either vitamins or minerals supplements may improve the immune function in older subjects [2-5 ]. Therefore, it is plausible to assume that improvement of their nutritional status through MVM supplements may benefit their ability to fight infections. The hormonal and physiological deregulation in aging might also benefit from MVM adding to the body effectiveness to deal with common pathogens in aging.

A previous systematic review and meta-analysis of randomised controlled trials (RCT), which included papers published before January 2004, found no evidence of an effect of MVM supplementation on infection rate [6] or duration [7] in older people. However, considerable clinical and methodological heterogeneity was present in the studies included in this earlier review. The investigators have updated this earlier systematically review of the evidence that MVM supplementation is effective in reducing the incidence of infection in older people. Sub-group analysis explored the effect site of residence (nursing homes or dwellings) of study participants, primary outcome measure (self report or clinical evaluation), and baseline micronutrients status of enrolled subjects [8].

The investigators found no evidence of benefits from multivitamin and minerals supplementation on the rate of infection or the odds ratio of infection in aging subjects. The investigators also found no benefit of intervention in the subgroups analysed. Sensitivity analysis of those studies evaluated as free of bias did not substantially alter this conclusion.

The included trials were heterogeneous in sample size (range 33 to 2799), duration (range 4 to 24 months), and outcome measures. The lack of benefit of the intervention in studies which found variable percent of subjects with some micronutrient deficiencies at enrolment could be related to some characteristics of the included trials: All studies but that of Avenell [9] had not determined the micronutrients status of the target population before the enrolment. Therefore, the formulas of multivitamin and mineral supplements used were not aimed to correct any pre-specified deficiency. Moreover, those studies had different considerations to define the formula, which explains the large variability of the supplements across the studies. Finally, the assessment of the micronutrient status was also variable across the studies: dietary intake evaluation and/or micronutrients blood concentration, which affects the consistency of this subgroup meta-analysis.

It is noteworthy that all studies except one [10] have been carried out in developed countries where the nutritional status of aging populations seems to be better than that reported by studies carried out in developing countries. In fact, although the variability of the assessment methods do not allow to draw a clear conclusion on the baseline nutritional status of the subjects included in the analysed studies, the prevalence of deficiencies and the number of micronutrients found deficient are evidently lower than those referred in studies from developing countries such as those carried out in Ecuador [11]. The remaining study was carried out in a middle-income country and although data on baseline nutritional status of enrolled subjects was not published, presumably their micronutrient status is somehow similar to that found in developed countries.

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
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥65 years
  • Mental competence
  • Written informed consent

排除标准

  • Tuberculosis
  • Immunosuppressive therapeutics.

结局指标

主要结局

Incidence of respiratory infections (upper plus lower)

时间窗: 52 weeks

次要结局

  • Mean score of DTH response to Trichophyton and tetanus toxoid(52 weeks)
  • CRP blood concentration(52 weeks)
  • Cathelicidin concentration in supernatants of cultured respiratory mucosa cells(52 weeks)

研究者

发起方
Corporacion Ecuatoriana de Biotecnologia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fernando Sempertegui MD

Principal Investigator

Corporacion Ecuatoriana de Biotecnologia

研究点 (1)

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