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

NCT01484756 | Completed Phase 3 DMC

• 1 other identifier: FK-RKK-2819
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Respiratory Tract Infection

Keywords

respiratory infection; independent elderly; zinc; vitamins

Outcome Measures

Primary Outcomes (1)

• upper respiratory infection

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

  6 months

Secondary Outcomes (1)

• upper respiratory infection

  6 months

Study Arms (2)

calcium carbonate 500 mg

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

daily multi micronutrient supplement

EXPERIMENTAL

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

Dietary Supplement: daily multi micronutrient supplement

Interventions

daily multi micronutrient supplement DIETARY_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

Also known as: Zinc and vitamins for respiratory infection in older persons

daily multi micronutrient supplement

Placebo DIETARY_SUPPLEMENT

calcium carbonate 500 mg

calcium carbonate 500 mg

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women and men aged 60 years and above
• apparently healthy
• independent
• not taking supplementation during the last month

You may not qualify if:

• dementia or uncontrolled hypertension
• physically handicapped
• post cataract extraction

Sponsors & Collaborators

• Trisakti University: lead

Study Sites (1)

Faculty of Medicine, University of Indonesia

Jakarta, Jakarta Special Capital Region, 10430, Indonesia

Location

Related Publications (2)

• 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.

  PMID: 16081445 BACKGROUND

• 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.

  PMID: 12614088 BACKGROUND

Related Links

• Click here for more information about this study

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

Zinc; Vitamins; Cold Temperature

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Temperature; Thermodynamics; Physical Phenomena; Weather; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Study Officials

• Rina K Kusumaratna, Dr

  Faculty of Medicina, Trisakti University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Combined vitamins and minerals decrease incidence of upper respiratory tract infections in older persons

Study Record Dates

• First Submitted: November 15, 2011
• First Posted: December 2, 2011
• Study Start: August 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: March 1, 2009
• Last Updated: December 6, 2011

Record last verified: 2011-12

Locations

ID (1)