MedDataX Logo

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

NCT ID: NCT01484756

Last Updated: 2011-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Upper Respiratory Tract Infection

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

respiratory infection independent elderly zinc vitamins

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

calcium carbonate 500 mg

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

calcium carbonate 500 mg

daily multi micronutrient supplement

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

Group Type EXPERIMENTAL

daily multi micronutrient supplement

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

calcium carbonate 500 mg

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Zinc and vitamins for respiratory infection in older persons

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Trisakti University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rina K Kusumaratna

Combined vitamins and minerals decrease incidence of upper respiratory tract infections in older persons

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rina K Kusumaratna, Dr

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicina, Trisakti University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Medicine, University of Indonesia

Jakarta, Jakarta Special Capital Region, Indonesia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Indonesia

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 16081445 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12614088 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.univmed.org

Click here for more information about this study

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FK-RKK-2819

Identifier Type: -

Identifier Source: org_study_id