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

November 15, 2011
December 5, 2011
August 2008
February 2009   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01484756 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Combined Vitamins and Minerals Decrease Incidence of Upper Respiratory Tract Infections in Older Persons
Combined Vitamins and Minerals Decrease Incidence of Upper Respiratory Tract Infections in Older Persons

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Upper Respiratory Tract Infection
  • 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
  • Dietary Supplement: Placebo
    calcium carbonate 500 mg
  • Placebo Comparator: calcium carbonate 500 mg
    Control group received one daily tablet of calcium carbonate 500 mg for 6 months
    Intervention: Dietary Supplement: Placebo
  • Experimental: daily multi micronutrient supplement
    Experimental group received one daily multi micro-nutrient supplement tablet for 6 months
    Intervention: Dietary Supplement: daily multi micronutrient supplement

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
270
March 2009
February 2009   (final data collection date for primary outcome measure)

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
Both
60 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Indonesia
 
NCT01484756
FK-RKK-2819
Yes
Rina K Kusumaratna, Trisakti University
Trisakti University
Not Provided
Principal Investigator: Rina K Kusumaratna, Dr Faculty of Medicina, Trisakti University
Trisakti University
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP