Please select the eligibility criteria that correspond to the clinical trial below.
Title: The SU.VI.MAX Study. A Randomized, Placebo-controlled Prevention Trial of the Health Effects of Antioxidant Vitamins and Minerals.
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.


Options:
A: Inclusion Criteria:

* women aged 35-60 years, men aged 45-60 years
* acceptance of the possibility to be given a placebo and acceptance of the constraints of participation
* lack of previous regular supplementation with any of the vitamins or minerals in the supplement provided
* absence of extreme beliefs or behavior regarding diet

Exclusion Criteria:

* disease likely to hinder active participation or threatened 5-year survival
B: Inclusion Criteria:

* Men or women aged 60-85, inclusive
* Diagnosis of probable Alzheimer's disease
* English-speaking; Spanish-speaking if individual site allows
* Study partner or caregiver to assure compliance
* Mini-Mental State Examination score at screening visit greater than 14
* Female participants either surgically sterile or postmenopausal for over 1 year
* Stable medical condition for 3 months prior to screening, with no significant abnormal liver, kidney, or blood studies
* Stable medications for 4 weeks prior to screening
* Able to take oral medications
* Modified Hachinski Ischemic Index less than or equal to 4
* CT or MRI since onset of memory impairment demonstrating the absence of a clinically significant focal lesion
* Physically acceptable for this study as confirmed by medical history, physical exam, neurological exam, and clinical tests

Exclusion Criteria:

* Significant neurologic disease such as Parkinson's disease, stroke, brain tumor, multiple sclerosis, or seizure disorder
* Major depression in the past 12 months, major mental illness such as schizophrenia, or recent (in past 12 months) alcohol or substance abuse
* History of invasive cancer within the past two years (excluding non-melanoma skin cancer)
* Contra-indications to lumbar puncture
* Use of any investigational agents within 30 days prior to screening
* Major surgery within 8 weeks prior to the Baseline Visit
* Uncontrolled cardiac conditions or severe unstable medical illnesses
* Antiretroviral therapy for human immunodeficiency virus (HIV)
* Conditions that will contribute to oxidative stress: current cigarette or cigar smokers (within past month), diabetics on insulin or poorly controlled on oral hypoglycemics
* Residence in skilled nursing facility
* Blindness, deafness, language difficulties or any other disability which may prevent the participant from participating or cooperating in the protocol

Note: Exceptions to these criteria may be considered on a case-by-case basis, at the discretion of the Project Director.

Excluded Medications:

* Experimental drugs
* Coumadin
* Insulin
* Immunosuppressive agents: prednisone and other corticosteroids (taken orally or by injection), methotrexate, cyclophosphamide, cyclosporin, tacrolimus, etc.
* HIV protease inhibitors
* Neuroleptics and lithium
* Anti-cancer agents (exception: stable doses of hormonal therapy, e.g. Lupron, estrogen, are permitted)
C: Inclusion Criteria:

* The study will enroll subjects, both men and women with type 2 diabetes of at least six months duration. The age of enrolled subjects will range from 21-60 years old. An HbA1c blood test must show that the person's diabetes is under control. Eligible subjects must have normal electrocardiogram tracings and normal hematological, electrolyte and liver laboratory results at screening. Females of childbearing age must agree to use an effective form of birth control throughout the study period.

Exclusion Criteria:

* Subjects will be excluded if they have known vascular disease, uncontrolled hypertension (\>140/90 mmHg), marked hyperlipidemia (serum low density lipoprotein \> 4.1 mmol/L or serum triglycerides \> 7.8 mmol/L), and a body mass index greater than 40 kg/m2 (range 27-40). Other important exclusion criteria are cigarette smoking, volunteers taking Coumadin, and recent use of antioxidant supplements or aspirin. Females who are pregnant or breastfeeding will be excluded. People cannot participate in this study if they are taking medications (other than antidiabetic medications) which may affect blood sugar.
D: INCLUSION CRITERIA

1. DISEASE CHARACTERISTICS:

   * Healthy male physicians practicing in the United States
   * Prior participation in the Physicians' Health Study I allowed
2. PATIENT CHARACTERISTICS:

   * Aged 50 years and over
   * No history of serious illness that would preclude study participation
   * No history of significant adverse events (e.g., rash or allergic reaction) attributed to study agents
3. PRIOR CONCURRENT THERAPY:

   * No other concurrent vitamin and/or multivitamin supplementation
   * No concurrent vitamin K-depleting anticoagulants (e.g., warfarin)

Answer: A