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| ID | Type | Description | Link |
|---|---|---|---|
| U01HL050981 | U.S. NIH Grant/Contract | View source | |
| M01RR000052 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
| National Center for Research Resources (NCRR) | NIH |
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High levels of homocysteine, which is an amino acid in the blood, have been linked to an increased risk of heart disease. This study will examine the effect that differing levels of folic acid have on reducing homocysteine levels among older adults.
Elevated levels of homocysteine may be a risk factor for coronary heart disease, stroke, and peripheral vascular disease. Folate is a type of B vitamin that occurs naturally in food. In nutritional supplements, folate is known as folic acid, and it has been shown to lower the concentration of homocysteine in blood. Folic acid supplements are a simple way for people to increase their folate intake, lower their homocysteine levels, and reduce their risk of developing heart disease. However, more research is required to determine the most effective dose of folic acid needed to lower homocysteine levels. The purpose of this study is to examine the effect that varying doses of folic acid have on folate levels and homocysteine concentration levels in older adults.
This 6-week study will enroll healthy adults over the age of 60 who do not currently take multivitamins or B-vitamins. At a screening visit, participants will complete questionnaires on medical history, demographics, and diet. Also, height and weight will be measured, and a blood collection will occur. At a baseline study visit, participants will be randomly assigned to receive either placebo or one of four doses of folic acid-100 mcg, 400 mcg, 1000 mcg, or 2000 mcg-to be taken once a day for 6 weeks. Participants will attend a final study visit at Week 6, at which time another blood collection will occur.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Participants will receive placebo folic acid. |
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| 2 | Experimental | Participants will receive 100 mcg of folic acid. |
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| 3 | Experimental | Participants will receive 400 mcg of folic acid. |
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| 4 | Experimental | Participants will receive 1000 mcg of folic acid. |
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| 5 | Experimental | Participants will receive 2000 mcg of folic acid. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Folic Acid | Dietary Supplement | 100 mcg, 400 mcg, 1000 mcg, or 2000 mcg of folic acid once a day for 6 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Plasma homocysteine levels | Measured at Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum folate levels | Measured at Week 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence J. Appel, MD, MPH | Johns Hopkins University | Principal Investigator |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Placebo Folic Acid | Drug | Placebo folic acid once a day for 6 weeks |
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| D006571 | Heterocyclic Compounds |