Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00272428
Status:
COMPLETED
Last Update Posted:
2009-12-17
First Post:
2006-01-03
Brief Title:
Primary Prevention Trial of the Health Effects of Antioxidant Vitamins and Minerals
Sponsor:
Institut National de la Santé Et de la Recherche Médicale France
Organization:
Institut National de la Santé Et de la Recherche Médicale France
Study Overview
Official Title:
The SUVIMAX Study A Randomized Placebo-controlled Prevention Trial of the Health Effects of Antioxidant Vitamins and Minerals
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It has been suggested that a low dietary intake of antioxidant vitamins and minerals increases the incidence rate of cardiovascular disease and cancer To date however the published results of randomized placebo-controlled trials of supplements containing antioxidant nutrients have not provided clear evidence of a beneficial effect We tested the efficacy of nutritional doses of supplementation with a combination of antioxidant vitamins and minerals in reducing the incidence of cancer and ischemic cardiovascular disease in the general population
Detailed Description:
From experimental studies it is known that free radicals may induce numerous pathological processes and it has been suggested that because of their antioxidant capacity nutrients such as beta-carotene vitamin C vitamin E selenium and zinc may prevent such harmful effects Epidemiological data from cross-sectional case-control and prospective studies have indeed shown a strong relationship between the intake of antioxidant vitamins and minerals or foods rich in these nutrients and the risk of cancer and ischaemic cardiovascular diseases CVD However randomised placebo-controlled primary prevention trials in which antioxidant micronutrients alone or in pairs were given at high doses over long periods have not been able to prove this potential beneficial effect and two of these even suggested harmful effects The seemingly contradictory results between the observational studies and these randomised trials can be explained by the fact that the doses used in clinical trials were much higher than the highest levels reachable by usual dietary intake which have been found to be associated in observational studies with the lowest risk of cancer and CVD In fact the only trial which did observe a beneficial effect on total mortality and cancer incidence used nutritional doses of a combination of several vitamins and minerals and was performed on Chinese population with very low baseline micronutrient status due to poor life conditions in this region 9
The objective of the SUpplementation en VItamines et Minéraux AntioXydants SUVIMAX study was to test in a randomised placebo-controlled trial if an adequate and well balanced intake of antioxidant nutrients reduces the incidence of cancers and ischaemic cardiovascular diseases in a middle-age general population
The objective of the SUpplementation en VItamines et Minéraux AntioXydants SUVIMAX study was to test in a randomised placebo-controlled trial if an adequate and well balanced intake of antioxidant nutrients reduces the incidence of cancers and ischaemic cardiovascular diseases in a middle-age general population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None