Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000161
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
1999-09-23
Brief Title:
Randomized Trials of Vitamin Supplements and Eye Disease
Sponsor:
National Eye Institute NEI
Organization:
National Eye Institute NEI
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2001-09
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
To determine whether vitamin E supplementation reduces the risk of cataract and age-related macular degeneration AMD in women
To determine whether vitamin C supplementation reduces the risk of cataract and AMD in women
To determine whether beta-carotene supplementation reduces the risk of cataract and AMD in women
To determine whether alternate day low-dose aspirin reduces the risk of cataract and AMD in women
To identify potential risk factors for cataract and AMD including cigarette smoking alcohol intake blood pressure blood cholesterol cardiovascular disease height body mass index and diabetes
To determine whether vitamin C supplementation reduces the risk of cataract and AMD in women
To determine whether beta-carotene supplementation reduces the risk of cataract and AMD in women
To determine whether alternate day low-dose aspirin reduces the risk of cataract and AMD in women
To identify potential risk factors for cataract and AMD including cigarette smoking alcohol intake blood pressure blood cholesterol cardiovascular disease height body mass index and diabetes
Detailed Description:
Cataract and AMD are two of the most important causes of visual impairment in older Americans Approximately 33 million people have visual impairment due to cataract Cataract extraction although one of the safest and most successful of all operations is now the most frequently performed operation in the United States among persons older than 60 costing an estimated 15 billion annually AMD is the leading cause of new cases of blindness in persons aged 65 and older Approximately 25 percent of persons aged 65 years and older have signs of AMD The pathogenesis of AMD however is only partly understood and its etiology remains obscure For most patients there is no available treatment The public health burden imposed by cataract and AMD will only increase in the coming decades as the US population ages
These randomized double-masked placebo-controlled trials will test the hypotheses that supplementation with antioxidant vitamins and with low-dose aspirin reduces the risk of age-related cataract and AMD The study populations are the Womens Health Study WHS and the Womens Antioxidant Cardiovascular Study WACS The WHS is a randomized double-masked placebo-controlled trial using a 2x2 factorial design to test low-dose aspirin 100 mg on alternate days and vitamin E 600 IU on alternate days in the primary prevention of cardiovascular disease CVD and cancer It is being conducted among 39876 apparently healthy female health professionals age 45 years and older The WACS is a randomized double-masked placebo-controlled secondary prevention trial using a 2x2x2x2 factorial design to test antioxidant vitamins vitamins E 600 IU on alternate days and C 500 mg daily beta carotene 50 mg on alternate days and a combination of folate 800 mg daily vitamin B6 25 mg daily and vitamin B12 1 mg daily among women who are at high risk for CVD morbidity and mortality It is being conducted among 8171 female health professionals ages 40 years or older who either have preexisting CVD or have at least three coronary risk factors and therefore are at high risk for the development of CVD
In addition to the randomized comparisons the investigators will also examine risk factors for age-related cataract and AMD in these two populations Factors to be examined include cigarette smoking alcohol intake blood pressure blood cholesterol cardiovascular disease height body mass index diabetes and dietary factors
In each study population followup questionnaires were sent at 6 and 12 months after randomization and every 12 months thereafter requesting information about development of relevant study end points including cataract and AMD and participant compliance with study medications Reported diagnoses of cataract and AMD are confirmed by medical record review The primary analysis for the randomized studies will be incidence of AMD or cataract in the treatment and placebo groups Survival analysis will be used to determine whether there is a difference in time to AMD or cataract diagnosis
These randomized double-masked placebo-controlled trials will test the hypotheses that supplementation with antioxidant vitamins and with low-dose aspirin reduces the risk of age-related cataract and AMD The study populations are the Womens Health Study WHS and the Womens Antioxidant Cardiovascular Study WACS The WHS is a randomized double-masked placebo-controlled trial using a 2x2 factorial design to test low-dose aspirin 100 mg on alternate days and vitamin E 600 IU on alternate days in the primary prevention of cardiovascular disease CVD and cancer It is being conducted among 39876 apparently healthy female health professionals age 45 years and older The WACS is a randomized double-masked placebo-controlled secondary prevention trial using a 2x2x2x2 factorial design to test antioxidant vitamins vitamins E 600 IU on alternate days and C 500 mg daily beta carotene 50 mg on alternate days and a combination of folate 800 mg daily vitamin B6 25 mg daily and vitamin B12 1 mg daily among women who are at high risk for CVD morbidity and mortality It is being conducted among 8171 female health professionals ages 40 years or older who either have preexisting CVD or have at least three coronary risk factors and therefore are at high risk for the development of CVD
In addition to the randomized comparisons the investigators will also examine risk factors for age-related cataract and AMD in these two populations Factors to be examined include cigarette smoking alcohol intake blood pressure blood cholesterol cardiovascular disease height body mass index diabetes and dietary factors
In each study population followup questionnaires were sent at 6 and 12 months after randomization and every 12 months thereafter requesting information about development of relevant study end points including cataract and AMD and participant compliance with study medications Reported diagnoses of cataract and AMD are confirmed by medical record review The primary analysis for the randomized studies will be incidence of AMD or cataract in the treatment and placebo groups Survival analysis will be used to determine whether there is a difference in time to AMD or cataract diagnosis
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