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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03073369
• Other study ID #: F170216006
• Status: Withdrawn
• Phase: Phase 4
• First received: February 28, 2017
• Last updated: March 14, 2018
• Start date: January 1, 2018
• Est. completion date: December 2018

Study information

• Verified date: March 2018
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Chronic Kidney Diseases
• CKD
• Ergocalciferol
• Hepcidin
• Iron-deficiency
• Kidney Diseases
• Renal Insufficiency, Chronic
• Vitamin D

Intervention

Drug:
• Ergocalciferol 50000 UNT
Oral Ergocalciferol 50000 IU once daily for 6 weeks
• Placebo
Oral Placebo - one capsule once daily for 6 weeks

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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