跳至主要内容
临床试验/NCT03258970
NCT03258970已完成不适用

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

Centre Hospitalier Universitaire Vaudois1 个研究点 分布在 1 个国家目标入组 2,711 人开始时间: 2017年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,711
试验地点
1
主要终点
Grip strength

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Grip strength

时间窗: 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.

次要结局

  • Low grip strength(Between April 2009 and September 2012, and 5.5 years afterwards)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pedro Marques-Vidal

Associate professor

Centre Hospitalier Universitaire Vaudois

研究点 (1)

Loading locations...

相似试验

已完成
不适用
The effect of Vitamins C and E supplementation in athlete womeSports Nutrition.Other general examinations
IRCT201111095062N2Isfahan University of Medical Sciences60
已完成
2 期
Effect of Vitamin C and Vitamin E Supplementation on Postprandial Oxidative Stress, Inflammatory Markers, Lipid Profile , Insulin and Blood Glucose Level of Type 2 Diabetic Patientsdiabetes mellitus.Non-insulin-dependent diabetes mellitus
IRCT138904073236N1Shiraz Uuniversity Of Medical Sciences45
尚未招募
不适用
A study of the effects of Vitamin C and Vitamin E supplementation on the rate of wound healing in diabetic foot ulcers - A Randomized Controlled Trial.
CTRI/2021/08/035385JIPMER
已完成
不适用
effect of vitamins E and C on lipid profile in elderlyCondition 1: Pure hypercholesterolaemia. Condition 2: Mixed hyperlipidaemia. Condition 3: Other hyperlipidaemia. Condition 4: Lipoprotein deficiency. Condition 5: Hyperlipidaemia, unspecified.Familial hypercholesterolaemiaFredrickson hyperlipoproteinaemia, type IIaHyperbetalipoproteinaemiaHyperlipidaemia, group ALow-density-lipoprotein-type [LDL] hyperlipoproteinaemiaBroad- or floating-betalipoproteinaemiaFredrickson hyperlipoproteinaemia, type IIb or IIIHyperbetalipoproteinaemia with prebetalipoproteinaemiaHypercholesterolaemia with endogenous hyperglyceridaemiaHyperlipidaemia, group CTubero-eruptive xanthomaXanthomaFamilial combined hyperlipidaemiaAbetalipoproteinaemiaHigh-density lipoprotein deficiencyHypoalphalipoproteinaemiaHypobetalipoproteinaemia (familial)Lecithin cholesterol acyltransferase deficiencyTangier disease
IRCT2014052517831N1Tehran University of Medical Sciences210
尚未招募
3 期
The effect of vitamin E and C on risk factors of coronary artery disease (CAD)
IRCT20180804040688N1Gonabad University of Medical Sciences88