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

Sponsor
Trisakti University (Other)
Overall Status
Completed
CT.gov ID
NCT01484756
Collaborator
(none)
270
1
2
7
38.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: daily multi micronutrient supplement
  • Dietary Supplement: Placebo
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
270 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Combined Vitamins and Minerals Decrease Incidence of Upper Respiratory Tract Infections in Older Persons
Study Start Date :
Aug 1, 2008
Actual Primary Completion Date :
Feb 1, 2009
Actual Study Completion Date :
Mar 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: calcium carbonate 500 mg

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

Dietary Supplement: Placebo
calcium carbonate 500 mg

Experimental: daily multi micronutrient supplement

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

Dietary Supplement: daily multi micronutrient supplement
Multi micro-nutrient supplement tablet containing 40 mg elemental zinc (as gluconate, 120 mg ascorbic acid, 6 mg beta-carotene, 15 mg alpha-tocopherol (as d-alpha-tocopheryl acid succinate, 400 micrograms folic acid in experimental group given daily for six months
Other Names:
  • Zinc and vitamins for respiratory infection in older persons
  • Outcome Measures

    Primary Outcome Measures

    1. upper respiratory infection [6 months]

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

    Secondary Outcome Measures

    1. upper respiratory infection [6 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Medicine, University of Indonesia Jakarta Indonesia 10430

    Sponsors and Collaborators

    • Trisakti University

    Investigators

    • Principal Investigator: Rina K Kusumaratna, Dr, Faculty of Medicina, Trisakti University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Rina K Kusumaratna, Combined vitamins and minerals decrease incidence of upper respiratory tract infections in older persons, Trisakti University
    ClinicalTrials.gov Identifier:
    NCT01484756
    Other Study ID Numbers:
    • FK-RKK-2819
    First Posted:
    Dec 2, 2011
    Last Update Posted:
    Dec 6, 2011
    Last Verified:
    Dec 1, 2011
    Keywords provided by Rina K Kusumaratna, Combined vitamins and minerals decrease incidence of upper respiratory tract infections in older persons, Trisakti University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 6, 2011