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

NCT ID: NCT03073369

Last Updated: 2018-03-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2018-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Oral Ergocalciferol

Oral Ergocalciferol 50000 IU once daily for 6 weeks

Group Type: ACTIVE_COMPARATOR

Ergocalciferol 50000 UNT

Intervention Type: DRUG

Oral Ergocalciferol 50000 IU once daily for 6 weeks

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral Placebo - one capsule once daily for 6 weeks

Interventions

Ergocalciferol 50000 UNT

Oral Ergocalciferol 50000 IU once daily for 6 weeks

Intervention Type: DRUG

Placebo

Oral Placebo - one capsule once daily for 6 weeks

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Bhupesh Panwar, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

F170216006

Identifier Type: -

Identifier Source: org_study_id