Effect of Ergocalciferol on Iron Metabolism in Individuals With Chronic Kidney Disease

Study Overview
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Brief Summary
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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.

Official Title
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Targeting the Interactions Between Disordered Iron Homeostasis and Mineral Metabolism in Chronic Kidney Disease (Aim 1)

Conditions
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CKD, Chronic Kidney Diseases, Hepcidin, Ergocalciferol, Vitamin D, Iron-deficiency, Anemia

Intervention / Treatment
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* Drug: Ergocalciferol 50000 UNT
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants 19 years or older with mild to moderate CKD (eGFR 15 - 59 ml/min/1.73 m2) by the CKD-EPI formula, with vitamin D deficiency (25(OH)D < 30 ng/ml), and with absolute iron deficiency (TSAT < 20 and Ferritin <100) or iron restriction (TSAT < 20 and Ferritin > 100). Exclusion Criteria: Active vitamin D analog therapy or history of recent (< 3 months) use. Nutritional vitamin D (cholecalciferol or ergocalciferol) therapy in dosages greater than 2000 IU/day. Subjects receiving erythropoiesis stimulating agents or intravenous iron therapy. Oral iron therapy started within the last 3 months. Hb < 8.0 g/dL for males and Hb <7.0 g/dL for females. Pregnancy or lactation. Serum calcium > 10.0 mg/dL or phosphorus > 4.5 mg/dL. Subjects with acute kidney injury or rapidly declining GFR. Subjects on hemodialysis, peritoneal dialysis, or having a functioning renal transplant. Focus of active inflammation such as acute gout, rheumatoid arthritis or active infection determined clinically.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral Ergocalciferol<br>Oral Ergocalciferol 50000 IU once daily for 6 weeks | Drug: Ergocalciferol 50000 UNT<br>* Oral Ergocalciferol 50000 IU once daily for 6 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Oral Placebo - one capsule once daily for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |