Frail Elderly SyndromeCoLausNCT03258970
No Association Between Vitamin C and E Supplementation, Frailty, and Grip Strength Over Five Years: The CoLaus Study
An observational study of Frail Elderly Syndrome, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
To assess the cross-sectional and 5-year prospective association between self-reported vitamin C+E dietary supplementation and markers of grip strength and frailty in community-dwelling Swiss adults. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Frail Elderly Syndrome
- What is being tested?
- Observational cohort study
- How many people
- 2,711 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2017to 10 Aug 2017
- Phase
- Observational
- 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 40 to 80 years
- All sexes
- Adult, Older adult
Study population: All inhabitants of Lausanne city, Switzerland, aged 35 to 75 at the time of the Baseline study (2003-2006)
Inclusion criteria Participation in the first follow-up of the CoLaus study Exclusion criteria for the cross-sectional study
- missing grip strength;
- missing covariates
- missing or suspicious body fat values Further exclusion criteria for the prospective analysis
- did not complete the second follow-up
- missing grip strength at the second follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
To assess the cross-sectional and 5-year prospective association between self-reported vitamin C+E dietary supplementation and markers of grip strength and frailty in community-dwelling Swiss adults.
Read the detailed description
Participants were drawn from the Colaus study, a prospective study designed to evaluate the prevalence of cardiovascular risk factors (CVRFs) and identify genetic determinants of these risk factors in an adult Swiss population. Details of the sampling procedure have been previously published (22) and can be located online (http://www.colaus.ch).
Recruitment for the baseline Colaus study began in June 2003 and ended in May 2006, enrolling 6733 participants. The first follow-up was performed between April 2009 and September 2012, 5.5 years on average after the collection of baseline data. The information collected was similar to that in the baseline examination but included questions regarding food consumption and physical activity for the first time. The second follow-up was performed between May 2014 and July 2016, 10.7 years on average after the collection of baseline data and applied similar methods to those in the first follow-up. For this study, data from the first and the second follow-ups were used.
All participants were examined in the morning after a fast of at least 8 hours. They were surveyed about their personal and family history of cardiovascular disease, CVRFs, and cardiovascular treatment. They also specified all prescribed and nonprescribed drugs used in the last 4 weeks, including dietary and vitamin supplements.
Vitamin supplement use Vitamin supplement use and dietary intake were evaluated using a self-administered, semi-quantitative food frequency questionnaire (FFQ). This FFQ includes 3 questions regarding the intake of vitamin C, vitamin E, and multivitamins and was previously validated in the nearby Geneva population (23, 24). In short, this questionnaire computes the previous 4 weeks' dietary intake and comprises 97 distinct food items that account for more than 90% of intake of calories, proteins, fat, carbohydrates, alcohol, cholesterol, vitamin D, and retinol and 85% of fibre, carotene, and iron. There does not yet exist an FFQ in Switzerland that can assess dietary intake for an entire year (25). Thus, this FFQ provides the most accurate dietary assessment available. The FFQs were completed by participants prior to their visits so the questionnaires could be reviewed by trained investigators in person.
Vitamin C+E users were defined as those who reported consumption of at least 0.5/day of either vitamin C or vitamin E supplements on the FFQ. As there are few single-vitamin supplements available in Switzerland and many MVM can contain either vitamin C or vitamin E or both, the investigators also considered MVM for sensitivity analysis. As many participants failed to provide the exact brand name of the MVM, it was not possible to calculate the exact intake of vitamin C or vitamin E (5). Vitamin D and/or calcium supplements were coded separately and were not included in the MVM category since most vitamin D and/or calcium supplements were prescribed for management of osteoporosis in women.
Other covariates Subjects were considered smokers if they smoked at the time of the interview; former smokers were defined as smokers who had quit smoking no matter how long before their interview; never smokers were defined as those who had never smoked. Educational level was categorized as low (primary), middle (apprenticeship or high school), and high (university) for highest completed level of education. Physical activity was assessed with a self-reported questionnaire previously validated in a population living in Geneva (28). This questionnaire considers the category and duration of 70 different forms of (non)professional activities and sports from the previous 7 days. Sedentary status was defined as expending more than 90% of daily energy expenditures in activities less intense than moderate- and high-intensity (defined by expending at least 4 times one's basal metabolic rate) (29, 30).
Body weight and height were measured while participants stood without shoes in light indoor attire. Body weight was measured in kilograms to the nearest 100 g using a Seca® scale (Hamburg, Germany) that was frequently calibrated. Height was measured to the nearest 5 mm using a Seca® (Hamburg, Germany) height gauge. Body composition was examined with electrical bioelectrical impedance using the Bodystat 1500 analyzer (Isle of Man, UK) that has been previously validated (31).
Other dietary (non-vitamin) supplements were obtained from the drug questionnaire given to all participants and include substances such as shark cartilage, cod liver oil, or plant extracts not registered as phytotherapy in the Swiss drug compendium.
- Conditions
- Frail Elderly Syndrome
- Being tested
- Observational cohort study
- Keywords
- vitamin supplement, Vitamin C, Vitamin E
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational cohort studyOther
taking vitamin supplements
What is being measured
The primary outcome is the main question the study is designed to answer.
Grip strength
Grip strength was assessed using the Baseline® Hydraulic Hand Dynamometer (Fabrication Enterprises Inc, Elmsford, NY, USA) with the subject seated, shoulders adducted and neutrally rotated, elbow flexed at 90°, forearm in neutral position, and wrist between 0 and 30° of dorsiflexion per American Society of Hand Therapists's guidelines (26). Three measurements were performed successively with the subject's right hand, and the highest value (expressed in kg), along with the participant's dominant hand choice, was recorded.
Measured: Between April 2009 and September 2012, and 5.5 years afterwards
Secondary outcomes (1)
Low grip strength
Grip strength was categorized as low (defined as frail in this study) or normal according to the Fried criteria, which also considers sex and body mass index (BMI).
Measured: Between April 2009 and September 2012, and 5.5 years afterwards
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start1 Jul 2017
- Primary completion10 Aug 2017
- Study completion10 Aug 2017
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 Frail Elderly SyndromeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,711 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro Marques-Vidal, Centre Hospitalier Universitaire Vaudois
- Investigators
- Peter Vollenweider, MD, Principal investigator, Centre Hospitalier Universitaire VaudoisGérard Waeber, MD, PhD, Principal investigator, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03258970
- Sponsor's protocol ID
- 2
- Acronym
- CoLaus
- Status last verified
- Aug 2017
- First submitted
- 14 Aug 2017
- Last updated
- 23 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Firmann M, Mayor V, Vidal PM, Bochud M, Pecoud A, Hayoz D, Paccaud F, Preisig M, Song KS, Yuan X, Danoff TM, Stirnadel HA, Waterworth D, Mooser V, Waeber G, Vollenweider P. The CoLaus study: a population-based study to investigate the epidemiology and genetic determinants of cardiovascular risk factors and metabolic syndrome. BMC Cardiovasc Disord. 2008 Mar 17;8:6. doi: 10.1186/1471-2261-8-6.
PubMed 18366642
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- No Association Between Vitamin C and E Supplementation, Frailty, and Grip Strength Over Five Years: The CoLaus Study
- ClinicalTrials.gov ID
- NCT03258970
- Acronym / sponsor ID
- CoLaus / 2
- Conditions
- Frail Elderly Syndrome
- Keywords
- vitamin supplement, Vitamin C, Vitamin E
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,711 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 10 Aug 2017 (actual)
- Study completion
- 10 Aug 2017 (actual)
- First posted
- 23 Aug 2017 (actual)
- 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.
To assess the cross-sectional and 5-year prospective association between self-reported vitamin C+E dietary supplementation and markers of grip strength and frailty in community-dwelling Swiss adults.
Detailed description
Participants were drawn from the Colaus study, a prospective study designed to evaluate the prevalence of cardiovascular risk factors (CVRFs) and identify genetic determinants of these risk factors in an adult Swiss population. Details of the sampling procedure have been previously published (22) and can be located online (http://www.colaus.ch).
Recruitment for the baseline Colaus study began in June 2003 and ended in May 2006, enrolling 6733 participants. The first follow-up was performed between April 2009 and September 2012, 5.5 years on average after the collection of baseline data. The information collected was similar to that in the baseline examination but included questions regarding food consumption and physical activity for the first time. The second follow-up was performed between May 2014 and July 2016, 10.7 years on average after the collection of baseline data and applied similar methods to those in the first follow-up. For this study, data from the first and the second follow-ups were used.
All participants were examined in the morning after a fast of at least 8 hours. They were surveyed about their personal and family history of cardiovascular disease, CVRFs, and cardiovascular treatment. They also specified all prescribed and nonprescribed drugs used in the last 4 weeks, including dietary and vitamin supplements.
Vitamin supplement use Vitamin supplement use and dietary intake were evaluated using a self-administered, semi-quantitative food frequency questionnaire (FFQ). This FFQ includes 3 questions regarding the intake of vitamin C, vitamin E, and multivitamins and was previously validated in the nearby Geneva population (23, 24). In short, this questionnaire computes the previous 4 weeks' dietary intake and comprises 97 distinct food items that account for more than 90% of intake of calories, proteins, fat, carbohydrates, alcohol, cholesterol, vitamin D, and retinol and 85% of fibre, carotene, and iron. There does not yet exist an FFQ in Switzerland that can assess dietary intake for an entire year (25). Thus, this FFQ provides the most accurate dietary assessment available. The FFQs were completed by participants prior to their visits so the questionnaires could be reviewed by trained investigators in person.
Vitamin C+E users were defined as those who reported consumption of at least 0.5/day of either vitamin C or vitamin E supplements on the FFQ. As there are few single-vitamin supplements available in Switzerland and many MVM can contain either vitamin C or vitamin E or both, the investigators also considered MVM for sensitivity analysis. As many participants failed to provide the exact brand name of the MVM, it was not possible to calculate the exact intake of vitamin C or vitamin E (5). Vitamin D and/or calcium supplements were coded separately and were not included in the MVM category since most vitamin D and/or calcium supplements were prescribed for management of osteoporosis in women.
Other covariates Subjects were considered smokers if they smoked at the time of the interview; former smokers were defined as smokers who had quit smoking no matter how long before their interview; never smokers were defined as those who had never smoked. Educational level was categorized as low (primary), middle (apprenticeship or high school), and high (university) for highest completed level of education. Physical activity was assessed with a self-reported questionnaire previously validated in a population living in Geneva (28). This questionnaire considers the category and duration of 70 different forms of (non)professional activities and sports from the previous 7 days. Sedentary status was defined as expending more than 90% of daily energy expenditures in activities less intense than moderate- and high-intensity (defined by expending at least 4 times one's basal metabolic rate) (29, 30).
Body weight and height were measured while participants stood without shoes in light indoor attire. Body weight was measured in kilograms to the nearest 100 g using a Seca® scale (Hamburg, Germany) that was frequently calibrated. Height was measured to the nearest 5 mm using a Seca® (Hamburg, Germany) height gauge. Body composition was examined with electrical bioelectrical impedance using the Bodystat 1500 analyzer (Isle of Man, UK) that has been previously validated (31).
Other dietary (non-vitamin) supplements were obtained from the drug questionnaire given to all participants and include substances such as shark cartilage, cod liver oil, or plant extracts not registered as phytotherapy in the Swiss drug compendium.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All inhabitants of Lausanne city, Switzerland, aged 35 to 75 at the time of the Baseline study (2003-2006)
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 |
|---|---|---|
| Observational cohort studytaking vitamin supplements | Other | – |
Primary outcome
Grip strength
Time frame: Between April 2009 and September 2012, and 5.5 years afterwards
Grip strength was assessed using the Baseline® Hydraulic Hand Dynamometer (Fabrication Enterprises Inc, Elmsford, NY, USA) with the subject seated, shoulders adducted and neutrally rotated, elbow flexed at 90°, forearm in neutral position, and wrist between 0 and 30° of dorsiflexion per American Society of Hand Therapists's guidelines (26). Three measurements were performed successively with the subject's right hand, and the highest value (expressed in kg), along with the participant's dominant hand choice, was recorded.
1 secondary outcome
Low grip strength
Time frame: Between April 2009 and September 2012, and 5.5 years afterwards
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 23 Aug 2017.
- Background: PubMed 18366642Firmann M, Mayor V, Vidal PM, Bochud M, Pecoud A, Hayoz D, Paccaud F, Preisig M, Song KS, Yuan X, Danoff TM, Stirnadel HA, Waterworth D, Mooser V, Waeber G, Vollenweider P. The CoLaus study: a population-based study to investigate the epidemiology and genetic determinants of cardiovascular risk factors and metabolic syndrome. BMC Cardiovasc Disord. 2008 Mar 17;8:6. doi: 10.1186/1471-2261-8-6.
- Individual participant dataSharing planned: No
Related trials for Frail Elderly Syndrome
Active, not recruiting
Implementing, Evaluating, and Scaling Up of the Strengthening a Palliative Approach in Long Term Care (SPA-LTC) Program
Frail Elderly Syndrome
Recruiting
Feasibility and Effects of Inspiratory Muscle Training Combined With Blood Flow Restriction for Frail Older Adults
Frailty Syndrome, Older Adults
Recruiting
Involvement of Muscle Mitochondrial Dysfunction in Frailty in Older Adults. Role of Exercise
Diabetes Type 2, Frail Elderly Syndrome
Not yet recruiting
Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults
Frailty Syndrome, Prefrail Elderly
Recruiting
The Impact of Geriatric Assessment on the Treatment Plan of Elderly Patients With T2DM
Type2diabetes, Frail Elderly Syndrome
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.
Peter Vollenweider, MD principal investigator
Centre Hospitalier Universitaire Vaudois
Gérard Waeber, MD, PhD principal investigator
Centre Hospitalier Universitaire Vaudois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frail Elderly Syndrome, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 23 Aug 2017. 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 Switzerland. 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.
What does the primary outcome measure?
Grip strength (time frame: Between April 2009 and September 2012, and 5.5 years afterwards). 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 NCT03258970, 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 23 Aug 2017.