Respiratory InfectionNCT00758914
Vitamin E and Infection in the Elderly
A study testing Vitamin E in people with Respiratory Infection and Elderly, run by Tufts University at 1 site in United States.
Trial summary
Aging is associated with a variety of changes in the immune system. These changes result in a less effective immune response, which places the elderly at a greater risk for infection and disease. Respiratory infections cause a great number of morbidity and mortality in the elderly population. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Infection, Elderly
- What is being tested?
- Vitamin E
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- May 1997to Aug 2001
- Phase
- Interventional
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- aged 65 years or older;
- life expectancy greater than 6 months;
- no anticipated discharge within 3 months;
- not room-bound for the past 3 months;
- absence of active neoplastic disease;
- no tube feeding, no kidney dialysis;
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- no intravenous or urethral catheters for the last 30 days;
- no tracheostomy or chronic ventilator;
- antibiotic-free for more than 2 weeks;
- no long-term steroid treatment greater than 10 mg/d, no use of immunosuppressive drugs, or greater than the recommended daily allowance (RDA) level of supplements of vitamins E, C, or B6, selenium, zinc, beta-carotene, or fish oil;
- body mass index of at least 18;
- serum albumin at least 3.0 g/dL; able to swallow pills;
- willing to receive influenza vaccine;
- willing to provide informed consent (for patients with dementia, family members provided informed consent)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Aging is associated with a variety of changes in the immune system. These changes result in a less effective immune response, which places the elderly at a greater risk for infection and disease. Respiratory infections cause a great number of morbidity and mortality in the elderly population. Vitamin E has been known to improve the immune response of the elderly and has been suggested for use in preventative strategies for this population. The purpose of this study is to examine the effect of one year vitamin supplementation on respiratory infection in the elderly population residing in nursing homes. This study was conducted using a randomized, double blind, placebo controlled clinical trial at 33 long-term care facilities in the greater Boston area. A total of 617 subjects over the age of 65 were enrolled in the study, with 451 completers. The participants were supplemented wit either 200 IU of vitamin E per day or placebo. The primary outcomes consisted of respiratory tract infection, number of sick days, and antibiotic use. The study involved use of questionnaires, standard anthropometrics measurements, non-invasive body composition, blood and urine sample collection, and delayed type test (DTH) using the Mantoux method. This study has been closed since August 2000 and is in the stage of data analysis only.
- Conditions
- Respiratory Infection, Elderly
- Being tested
- Vitamin E
- Keywords
- Vitamin E
- 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.
Vitamin EDietary supplement
200 IU alpha-tocopherol or placebo for 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startMay 1997
- Primary completionAug 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory 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 N/A
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00758914
- Sponsor's protocol ID
- 1R01AG013975
- Status last verified
- Sep 2008
- First submitted
- 22 Sep 2008
- Last updated
- 25 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Belisle SE, Hamer DH, Leka LS, Dallal GE, Delgado-Lista J, Fine BC, Jacques PF, Ordovas JM, Meydani SN. IL-2 and IL-10 gene polymorphisms are associated with respiratory tract infection and may modulate the effect of vitamin E on lower respiratory tract infections in elderly nursing home residents. Am J Clin Nutr. 2010 Jul;92(1):106-14. doi: 10.3945/ajcn.2010.29207. Epub 2010 May 19.
PubMed 20484443
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin E and Infection in the Elderly
- ClinicalTrials.gov ID
- NCT00758914
- Acronym / sponsor ID
- 1R01AG013975
- Conditions
- Respiratory Infection, Elderly
- Keywords
- Vitamin E
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- May 1997
- Primary completion
- Aug 2001 (actual)
- First posted
- 25 Sep 2008 (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.
Aging is associated with a variety of changes in the immune system. These changes result in a less effective immune response, which places the elderly at a greater risk for infection and disease. Respiratory infections cause a great number of morbidity and mortality in the elderly population. Vitamin E has been known to improve the immune response of the elderly and has been suggested for use in preventative strategies for this population. The purpose of this study is to examine the effect of one year vitamin supplementation on respiratory infection in the elderly population residing in nursing homes. This study was conducted using a randomized, double blind, placebo controlled clinical trial at 33 long-term care facilities in the greater Boston area. A total of 617 subjects over the age of 65 were enrolled in the study, with 451 completers. The participants were supplemented wit either 200 IU of vitamin E per day or placebo. The primary outcomes consisted of respiratory tract infection, number of sick days, and antibiotic use. The study involved use of questionnaires, standard anthropometrics measurements, non-invasive body composition, blood and urine sample collection, and delayed type test (DTH) using the Mantoux method. This study has been closed since August 2000 and is in the stage of data analysis only.
Study design
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (14 listed)
- aged 65 years or older;
- life expectancy greater than 6 months;
- no anticipated discharge within 3 months;
- not room-bound for the past 3 months;
- absence of active neoplastic disease;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Vitamin E200 IU alpha-tocopherol or placebo for 1 year. | Dietary supplement | – |
Primary outcome
Not reported in the source record.
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 25 Sep 2008.
- Derived from this study: PubMed 20484443Belisle SE, Hamer DH, Leka LS, Dallal GE, Delgado-Lista J, Fine BC, Jacques PF, Ordovas JM, Meydani SN. IL-2 and IL-10 gene polymorphisms are associated with respiratory tract infection and may modulate the effect of vitamin E on lower respiratory tract infections in elderly nursing home residents. Am J Clin Nutr. 2010 Jul;92(1):106-14. doi: 10.3945/ajcn.2010.29207. Epub 2010 May 19.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin E in people with Respiratory Infection and Elderly, run by Tufts University at 1 site in United States.
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 14 inclusion and 0 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 25 Sep 2008. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00758914, which also lists 1 linked publication.
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 25 Sep 2008.