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This is a single center, randomized, single-blind, placebo-controlled study to evaluate the safety and biochemical effects of niacinamide on metabolic parameters of the kidney in patients undergoing cardiac surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Niacinamide 1 gram | Active Comparator | Oral niacinamide, 1 gram daily |
|
| Niacinamide 3 grams | Active Comparator | Oral niacinamide, 3 grams daily |
|
| Placebo | Placebo Comparator | Oral placebo pill |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral niacinamide, 1 gram daily | Drug |
| ||
| Oral niacinamide, 3 gram daily |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in serum metabolite profile of niacinamide | Baseline and days 1 through 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in urine metabolite profile of niacinamide | Baseline and days 1 through 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | From enrollment through day 4, and at day 30 |
Inclusion criteria
Exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D009536 | Niacinamide |
| ID | Term |
|---|---|
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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| Drug |
|
| Placebo | Drug |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |