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No Association Between Vitamin C and E Supplementation, Frailty, and Grip Strength Over Five Years: The CoLaus Study (CoLaus)

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ClinicalTrials.gov Identifier: NCT03258970
Recruitment Status : Completed
First Posted : August 23, 2017
Last Update Posted : August 23, 2017
Sponsor:
Information provided by (Responsible Party):
Pedro Marques-Vidal, Centre Hospitalier Universitaire Vaudois

Tracking Information
First Submitted Date August 14, 2017
First Posted Date August 23, 2017
Last Update Posted Date August 23, 2017
Actual Study Start Date July 1, 2017
Actual Primary Completion Date August 10, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 21, 2017)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: August 21, 2017)
Low grip strength [ Time Frame: Between April 2009 and September 2012, and 5.5 years afterwards ]
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).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title No Association Between Vitamin C and E Supplementation, Frailty, and Grip Strength Over Five Years: The CoLaus Study
Official Title No Association Between Vitamin C and E Supplementation, Frailty, and Grip Strength Over Five Years: The CoLaus Study
Brief 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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Urine, blood and DNA samples available, but not used in this study
Sampling Method Probability Sample
Study Population All inhabitants of Lausanne city, Switzerland, aged 35 to 75 at the time of the Baseline study (2003-2006)
Condition Frail Elderly Syndrome
Intervention Other: Observational cohort study
taking vitamin supplements
Study Groups/Cohorts Not Provided
Publications * Firmann M, Mayor V, Vidal PM, Bochud M, Pécoud 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 21, 2017)
2711
Original Actual Enrollment Same as current
Actual Study Completion Date August 10, 2017
Actual Primary Completion Date August 10, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion criteria Participation in the first follow-up of the CoLaus study Exclusion criteria for the cross-sectional study

  1. missing grip strength;
  2. missing covariates
  3. missing or suspicious body fat values Further exclusion criteria for the prospective analysis
  4. did not complete the second follow-up
  5. missing grip strength at the second follow-up.
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03258970
Other Study ID Numbers 2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Pedro Marques-Vidal, Centre Hospitalier Universitaire Vaudois
Study Sponsor Centre Hospitalier Universitaire Vaudois
Collaborators Not Provided
Investigators
Principal Investigator: Peter Vollenweider, MD Centre Hospitalier Universitaire Vaudois
Principal Investigator: Gérard Waeber, MD, PhD Centre Hospitalier Universitaire Vaudois
PRS Account Centre Hospitalier Universitaire Vaudois
Verification Date August 2017