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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rina K Kusumaratna, Trisakti University
ClinicalTrials.gov Identifier:
NCT01484756
First received: November 15, 2011
Last updated: December 5, 2011
Last verified: December 2011
  Purpose

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 Intervention Phase
Upper Respiratory Tract Infection
Dietary Supplement: daily multi micronutrient supplement
Dietary Supplement: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Combined Vitamins and Minerals Decrease Incidence of Upper Respiratory Tract Infections in Older Persons

Resource links provided by NLM:


Further study details as provided by Trisakti University:

Primary Outcome Measures:
  • upper respiratory infection [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    This study measures number of new episodes of upper respiratory infection per total days of observation


Secondary Outcome Measures:
  • upper respiratory infection [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    This study measures number of days with upper respiratory infection per total days of observation


Enrollment: 270
Study Start Date: August 2008
Study Completion Date: March 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Zinc and vitamins for respiratory infection in older persons

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01484756

Locations
Indonesia
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
  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     History of Changes
Other Study ID Numbers: FK-RKK-2819
Study First Received: November 15, 2011
Last Updated: December 5, 2011
Health Authority: Indonesia: Departement Kesehatan (Department of Health)

Keywords provided by Trisakti University:
respiratory infection
independent elderly
zinc
vitamins

Additional relevant MeSH terms:
Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vitamins
Calcium Carbonate
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014