| What is homocysteine? | ||
| Homocysteine is produced when our body metabolizes protein. | ||
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| Why does homocysteine become elevated? | ||
| Homocysteine becomes elevated due to combined effects of aging, very poor intake or absorption of essential vitamins, decline in kidney function, rare genetic disorders, and, occasionally, use of certain medications. | ||
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| What foods are high in homocysteine? | ||
| Homocysteine is not found in foods. Please refer to #2. | ||
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| Why does homocysteine increase vascular risk? | ||
| We don’t know exactly; the relationship between homocysteine and vascular disease remains unclear. Until we clarify the relationship, including analyzing the results from FAVORIT, how or if homocysteine affects vascular disease remains unknown. | ||
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| Why is absorption of certain vitamins different? | ||
| Absorption depends on aging, diseases of the digestive tract, and whether vitamins are contained in whole foods or supplements. | ||
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| Why investigate Folic Acid, B6 & B12? | ||
| It is suggested that deficiencies in Folic Acid, B6 and B12 may contribute to the risk of developing cardiovascular disease. The information remains unclear. | ||
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| What foods are high in folic acid, B6, B12 vitamins? | ||
| Citrus fruits, tomatoes, vegetables and grain products are sources of folic acid. Since January 1998, wheat flour has been fortified with folic acid to add an estimated 100 micrograms per day to the average diet. Foods fortified with folic acid have the highest concentration (e.g. cereals). Vitamin B6 is found in beans, nuts, legumes, eggs, meats, fish, whole grains, and fortified breads and cereals. Vitamin B12 is found in eggs, meat, poultry, shellfish, and milk and milk products. | ||
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| How long will I be expected to stay in the study? | ||
| We expect the study will continue to collect data on participants until 2011. | ||
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| What tests do I have to undergo? | ||
| As part of the study, we will take your blood pressure, height and weight, and draw tubes of blood, collect a urine sample and conduct interviews at annual visits. No other tests for the study are required. | ||
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| Is hospitalization required? | ||
| No. | ||
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| What kinds of treatment can I expect to receive? | ||
| You will receive multivitamins free of charge from the study. Your usual clinical care will not be affected by participation in this study. | ||
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| Is there a chance that I might receive a placebo or sugar pill? | ||
| There is a 50-50 chance you will receive a placebo, but even the placebo contains Estimated Average Requirements of vitamins, except for Folic Acid. | ||
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| Will treatment affect my transplant or interfere with any of my other medications that I am currently taking? | ||
| No. | ||
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| Can I take other vitamins e.g., Vitamin A, Vitamin C, or Vitamin D while in the study? | ||
| Yes; you can take anything except Vitamins B6, B12 and Folic Acid while you’re in the study. | ||
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| Can I take a calcium supplement while in the study? | ||
| Yes. | ||
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| If I decide to take a medication similar to the high dose, can I pull out of the study? | ||
| You can withdraw at any time, though we hope you will stay for the length of the study. If you decide to take a medication similar to the high dose, despite the fact that we have no idea of benefit or harm, you can remain in the study. | ||
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| How would participating in this study affect my daily life? | ||
| Your daily life will be unaffected, except for taking the daily vitamins and the annual FAVORIT exams that are coordinated with your regular clinic visits. A brief telephone interview is conducted midway between the annual exams. | ||
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| What are some possible risks of participating in this study? | ||
| There are no known risks of participating in this study. | ||
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| What personal costs are involved? | ||
| None. The vitamins are given at no charge. | ||
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| What benefits can I expect as a participant? | ||
| There are no established benefits, and no evidence of toxicity. You will receive some reimbursement for your travel to the randomization visit, or for the screening/combination visit, and for parking at those visits. | ||
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| Will I be told if I have been taking the high or low dose medication, if yes when? | ||
| Yes, after the study is complete. | ||
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| If I decide to stop taking the study medication will I remain in the study. | ||
| Yes, we will ask that you continue to come in for your annual follow-up visits and be available for your telephone interview in between your in-person visits. | ||
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| Why should I participate in a clinical trial? | ||
| Clinical trials help physicians and the medical community decide which therapies or tests are useful to treat or diagnose disease. We can’t determine this without clinical trials, and your participation helps others. | ||
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