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Study didn't materialize for various reasons.
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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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The purpose of the study is to learn more about how treatment with vitamin D can affect iron metabolism and blood levels of hepcidin (hormone controlling iron levels) in people with chronic kidney disease (CKD).
Iron is an essential mineral which is a major component of proteins that carry oxygen in the blood. Problems with iron metabolism can lead to low blood levels (anemia), which can commonly happen in people with CKD.
New research over the last decade has uncovered a new hormone called 'hepcidin', which is made in the liver and released into the blood. Hepcidin controls how much iron is in the blood by preventing the absorption of iron from food. Blood levels of hepcidin C are found to be high in people with CKD, and a recent small study in people with normal kidney function showed that treatment with vitamin D decreased hepcidin levels.
In this study, investigators would like to examine the effects of vitamin D (Ergocalciferol) on iron metabolism and blood levels of hepcidin in individuals with CKD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Ergocalciferol | Active Comparator | Oral Ergocalciferol 50000 IU once daily for 6 weeks |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ergocalciferol 50000 UNT | Drug | Oral Ergocalciferol 50000 IU once daily for 6 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum hepcidin levels | Difference in change in serum hepcidin levels (ng/ml) over time between the two groups | At Day 0, Day 3, 1 week, 4 weeks and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum hemoglobin level | Difference in change in serum hemoglobin levels (g/dL) over time between the two groups | At Day 0, Day 3, 1 week, 4 weeks and 6 weeks |
| Change in serum ferritin level |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D018798 | Anemia, Iron-Deficiency |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Placebo |
| Drug |
Oral Placebo - one capsule once daily for 6 weeks |
|
Difference in change in serum ferritin levels (ng/ml) over time between the two groups
| At Day 0, Day 3, 1 week, 4 weeks and 6 weeks |
| Change in percent transferrin saturation | Difference in change in percent transferrin saturation (%) over time between the two groups | At Day 0, Day 3, 1 week, 4 weeks and 6 weeks |
| Change in serum iron level | Difference in change in serum iron levels (mcg/dL) over time between the two groups | At Day 0, Day 3, 1 week, 4 weeks and 6 weeks |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000747 | Anemia, Hypochromic |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000090463 | Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |