Upper Respiratory Tract Infection Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 270 |
Est. completion date | March 2009 |
Est. primary completion date | February 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 60 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Indonesia | Faculty of Medicine, University of Indonesia | Jakarta |
Lead Sponsor | Collaborator |
---|---|
Trisakti University |
Indonesia,
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | upper respiratory infection | This study measures number of new episodes of upper respiratory infection per total days of observation | 6 months | Yes |
Secondary | upper respiratory infection | This study measures number of days with upper respiratory infection per total days of observation | 6 months | Yes |
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