Effects of Vitamin D Replacement on Hormones Regulating Iron Metabolism in Individuals With Chronic Kidney Disease

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Chronic Kidney Disease, Anemia of Chronic Disease

In brief

The purpose of the study is to learn more about how treatment with vitamin D can affect iron metabolism and blood levels of two hormones that control iron levels, hepcidin and hemojuvelin 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. Another protein, known as 'hemojuvelin', has been recently discovered and is also thought to control the amount of iron in the blood. The relationship between vitamin D and hemojuvelin has never been studied before. In this study, investigators would like to examine the effects of vitamin D on iron metabolism and blood levels of hepcidin C and hemojuvelin in individuals with CKD.

Key facts

Study ID

NCT01988116

Run by

University of Alabama at Birmingham

People needed

40

Starts

2013-10-01

Expected to finish

2015-06-01

Last updated by the study team

2015-08-24

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with mild to moderate CKD (eGFR 15 - 60 ml/min/1.73 m2) as estimated by the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula.

You may not qualify if…

• Subjects currently receiving active vitamin D analog therapy or history of recent (< 3 months) use.
• Subjects currently receiving nutritional vitamin D (cholecalciferol or ergocalciferol) in dosages greater than 2000 IU/day.
• Subjects receiving erythropoiesis stimulating agents.
• Subjects receiving intravenous iron therapy.
• Subjects receiving oral iron therapy started within 3 months prior to recruitment.
• Subjects with severe anemia defined as Hb < 8.0 g/dL for males and Hb <7.0 g/dL for females.
• Subjects with iron deficiency anemia defined as serum ferritin <100ng/ml and Transferring Saturation < 20%.
• Pregnancy and lactation.
• Subjects with hypercalcemia defined as serum calcium level of > 10.0 mg/dL.
• Subjects with serum phosphorus concentration of > 4.5 mg/dL.
• Subjects with acute kidney injury or rapidly declining GFR.
• Subjects receiving any form of renal replacement therapy including hemodialysis, peritoneal dialysis, and patients with renal transplant.
• Subjects with focus of active inflammation or infection determined clinically.

Where it is running

• University of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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