Upper Respiratory Tract InfectionPhase 3NCT01484756
Combined Vitamins and Minerals Decrease Incidence of Upper Respiratory Tract Infections in Older Persons
A Phase 3 study testing daily multi micronutrient supplement in people with Upper Respiratory Tract Infection, run by Trisakti University at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Upper Respiratory Tract Infection
- What is being tested?
- daily multi micronutrient supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 1 siteIndonesia
- Study dates
- Aug 2008to Mar 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women and men aged 60 years and above
- apparently healthy
- independent
- not taking supplementation during the last month
Who cannot join
- dementia or uncontrolled hypertension
- physically handicapped
- post cataract extraction
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Faculty of Medicine, University of Indonesia
Jakarta, Jakarta Special Capital Region, 10430
About this study
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.
Read the 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.
- Conditions
- Upper Respiratory Tract Infection
- Being tested
- daily multi micronutrient supplement, Placebo
- Keywords
- respiratory infection, independent elderly, zinc, vitamins
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
daily multi micronutrient supplementDietary supplement
Also called Zinc and vitamins for respiratory infection in older persons
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
PlaceboDietary supplement
calcium carbonate 500 mg
| Study group | Role | What they receive |
|---|---|---|
| calcium carbonate 500 mg | Placebo comparator | Control group received one daily tablet of calcium carbonate 500 mg for 6 months Receives: Dietary Supplement: Placebo |
| daily multi micronutrient supplement | Experimental | Experimental group received one daily multi micro-nutrient supplement tablet for 6 months Receives: Dietary Supplement: daily multi micronutrient supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
upper respiratory infection
This study measures number of new episodes of upper respiratory infection per total days of observation
Measured: 6 months
Secondary outcomes (1)
upper respiratory infection
This study measures number of days with upper respiratory infection per total days of observation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startAug 2008
- Primary completionFeb 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Upper Respiratory Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trisakti University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rina K Kusumaratna, Trisakti University
- Investigators
- Rina K Kusumaratna, Dr, Principal investigator, Faculty of Medicina, Trisakti University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01484756
- Sponsor's protocol ID
- FK-RKK-2819
- Status last verified
- Dec 2011
- First submitted
- 15 Nov 2011
- Last updated
- 6 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16081445Barringer 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.
PubMed 12614088
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Vitamins and Minerals Decrease Incidence of Upper Respiratory Tract Infections in Older Persons
- ClinicalTrials.gov ID
- NCT01484756
- Acronym / sponsor ID
- FK-RKK-2819
- Conditions
- Upper Respiratory Tract Infection
- Keywords
- respiratory infection, independent elderly, zinc, vitamins
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Trisakti UniversityUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 2 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| calcium carbonate 500 mg | Placebo comparator | Dietary Supplement: PlaceboControl group received one daily tablet of calcium carbonate 500 mg for 6 months |
| daily multi micronutrient supplement | Experimental | Dietary Supplement: daily multi micronutrient supplementExperimental group received one daily multi micro-nutrient supplement tablet for 6 months |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- women and men aged 60 years and above
- apparently healthy
- independent
- not taking supplementation during the last month
Key exclusion criteria (3 listed)
- dementia or uncontrolled hypertension
- physically handicapped
- post cataract extraction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| daily multi micronutrient supplementAlso: Zinc and vitamins for respiratory infection in older personsMulti 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 | Dietary supplement | daily multi micronutrient supplement |
| Placebocalcium carbonate 500 mg | Dietary supplement | calcium carbonate 500 mg |
Primary outcome
upper respiratory infection
Time frame: 6 months
This study measures number of new episodes of upper respiratory infection per total days of observation
1 secondary outcome
upper respiratory infection
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2011.
- Background: PubMed 16081445Avenell 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.
- Background: PubMed 12614088Barringer 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.
- Click here for more information about this studyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rina K Kusumaratna, Dr principal investigator
Faculty of Medicina, Trisakti University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing daily multi micronutrient supplement in people with Upper Respiratory Tract Infection, run by Trisakti University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
upper respiratory infection (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01484756, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2011; AzTrials last refreshed its copy on 1 Nov 2026.