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

Phase 3

Completed

• Conditions: Upper Respiratory Tract Infection
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: daily multi micronutrient supplement

• Registration Number: NCT01484756
• Lead Sponsor: Trisakti University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2009-02
• Study Completion: 2009-03
• Study First Submitted: 2011-11-15
• Study First Submitted QC: 2011-11-30
• Status Verified: 2011-12
• Study First Posted: 2011-12-02
• Last Update Submitted: 2011-12-05
• Last Update Posted: 2011-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
calcium carbonate 500 mg	Placebo	Control group received one daily tablet of calcium carbonate 500 mg for 6 months
daily multi micronutrient supplement	daily multi micronutrient supplement	Experimental group received one daily multi micro-nutrient supplement tablet for 6 months

Primary Outcome Measures

Name	Time	Method
upper respiratory infection	6 months	This study measures number of new episodes of upper respiratory infection per total days of observation

Secondary Outcome Measures

Name	Time	Method
upper respiratory infection	6 months	This study measures number of days with upper respiratory infection per total days of observation

Trial Locations

Locations (1)

Faculty of Medicine, University of Indonesia; 🇮🇩 Jakarta, Indonesia