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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

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.

Condition or disease Intervention/treatment
Frail Elderly Syndrome Other: Observational cohort study

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 2711 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: No Association Between Vitamin C and E Supplementation, Frailty, and Grip Strength Over Five Years: The CoLaus Study
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : August 10, 2017
Actual Study Completion Date : August 10, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Vitamin C


Intervention Details:
  • Other: Observational cohort study
    taking vitamin supplements


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).


Biospecimen Retention:   Samples With DNA
Urine, blood and DNA samples available, but not used in this study


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258970


Locations
Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Investigators
Principal Investigator: Peter Vollenweider, MD Centre Hospitalier Universitaire Vaudois
Principal Investigator: Gérard Waeber, MD, PhD Centre Hospitalier Universitaire Vaudois

Publications:
Responsible Party: Pedro Marques-Vidal, Associate professor, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT03258970     History of Changes
Other Study ID Numbers: 2
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pedro Marques-Vidal, Centre Hospitalier Universitaire Vaudois:
vitamin supplement
Vitamin C
Vitamin E

Additional relevant MeSH terms:
Vitamins
Ascorbic Acid
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents