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

Phase 4

Withdrawn

• Conditions: CKD; Chronic Kidney Diseases; Anemia; Ergocalciferol; Vitamin D; Hepcidin; Iron-deficiency
• Interventions: Drug: Ergocalciferol 50000 UNT; Drug: Placebo

• Registration Number: NCT03073369
• Lead Sponsor: University of Alabama at Birmingham

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-28
• Study First Submitted QC: 2017-03-02
• Study First Posted: 2017-03-08
• Study Start: 2018-01-01
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-14
• Last Update Posted: 2018-03-15
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Ergocalciferol	Ergocalciferol 50000 UNT	Oral Ergocalciferol 50000 IU once daily for 6 weeks
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in serum hepcidin levels	At Day 0, Day 3, 1 week, 4 weeks and 6 weeks	Difference in change in serum hepcidin levels (ng/ml) over time between the two groups

Secondary Outcome Measures

Name	Time	Method
Change in serum hemoglobin level	At Day 0, Day 3, 1 week, 4 weeks and 6 weeks	Difference in change in serum hemoglobin levels (g/dL) over time between the two groups
Change in serum iron level	At Day 0, Day 3, 1 week, 4 weeks and 6 weeks	Difference in change in serum iron levels (mcg/dL) over time between the two groups
Change in percent transferrin saturation	At Day 0, Day 3, 1 week, 4 weeks and 6 weeks	Difference in change in percent transferrin saturation (%) over time between the two groups
Change in serum ferritin level	At Day 0, Day 3, 1 week, 4 weeks and 6 weeks	Difference in change in serum ferritin levels (ng/ml) over time between the two groups

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States