Combined Vitamins and Minerals Decrease Incidence of Upper Respiratory Tract Infections in Older Persons
Primary Purpose
Upper Respiratory Tract Infection
Status
Completed
Phase
Phase 3
Locations
Indonesia
Study Type
Interventional
Intervention
daily multi micronutrient supplement
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Upper Respiratory Tract Infection focused on measuring respiratory infection, independent elderly, zinc, vitamins
Eligibility 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
Sites / Locations
- Faculty of Medicine, University of Indonesia
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
calcium carbonate 500 mg
daily multi micronutrient supplement
Arm Description
Control group received one daily tablet of calcium carbonate 500 mg for 6 months
Experimental group received one daily multi micro-nutrient supplement tablet for 6 months
Outcomes
Primary Outcome Measures
upper respiratory infection
This study measures number of new episodes of upper respiratory infection per total days of observation
Secondary Outcome Measures
upper respiratory infection
This study measures number of days with upper respiratory infection per total days of observation
Full Information
NCT ID
NCT01484756
First Posted
November 15, 2011
Last Updated
December 5, 2011
Sponsor
Trisakti University
1. Study Identification
Unique Protocol Identification Number
NCT01484756
Brief Title
Combined Vitamins and Minerals Decrease Incidence of Upper Respiratory Tract Infections in Older Persons
Official Title
Combined Vitamins and Minerals Decrease Incidence of Upper Respiratory Tract Infections in Older Persons
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Trisakti University
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Respiratory Tract Infection
Keywords
respiratory infection, independent elderly, zinc, vitamins
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
270 (Actual)
8. Arms, Groups, and Interventions
Arm Title
calcium carbonate 500 mg
Arm Type
Placebo Comparator
Arm Description
Control group received one daily tablet of calcium carbonate 500 mg for 6 months
Arm Title
daily multi micronutrient supplement
Arm Type
Experimental
Arm Description
Experimental group received one daily multi micro-nutrient supplement tablet for 6 months
Intervention Type
Dietary Supplement
Intervention Name(s)
daily multi micronutrient supplement
Other Intervention Name(s)
Zinc and vitamins for respiratory infection in older persons
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
calcium carbonate 500 mg
Primary Outcome Measure Information:
Title
upper respiratory infection
Description
This study measures number of new episodes of upper respiratory infection per total days of observation
Time Frame
6 months
Secondary Outcome Measure Information:
Title
upper respiratory infection
Description
This study measures number of days with upper respiratory infection per total days of observation
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rina K Kusumaratna, Dr
Organizational Affiliation
Faculty of Medicina, Trisakti University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, University of Indonesia
City
Jakarta
ZIP/Postal Code
10430
Country
Indonesia
12. IPD Sharing Statement
Citations:
PubMed Identifier
16081445
Citation
Avenell A, Campbell MK, Cook JA, Hannaford PC, Kilonzo MM, McNeill G, Milne AC, Ramsay CR, Seymour DG, Stephen AI, Vale LD. Effect of multivitamin and multimineral supplements on morbidity from infections in older people (MAVIS trial): pragmatic, randomised, double blind, placebo controlled trial. BMJ. 2005 Aug 6;331(7512):324-9. doi: 10.1136/bmj.331.7512.324.
Results Reference
background
PubMed Identifier
12614088
Citation
Barringer TA, Kirk JK, Santaniello AC, Foley KL, Michielutte R. Effect of a multivitamin and mineral supplement on infection and quality of life. A randomized, double-blind, placebo-controlled trial. Ann Intern Med. 2003 Mar 4;138(5):365-71. doi: 10.7326/0003-4819-138-5-200303040-00005.
Results Reference
background
Links:
URL
http://www.univmed.org
Description
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Combined Vitamins and Minerals Decrease Incidence of Upper Respiratory Tract Infections in Older Persons
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