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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Kidney Diseases; Iron-deficiency; Anemia; CKD; Vitamin D; Hepcidin; Ergocalciferol
• Intervention / Treatment: Drug: Ergocalciferol 50000 UNT; Drug: Placebo

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: American Heart Association

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2018
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: February 28, 2017
• First Submitted That Met QC Criteria: March 2, 2017
• First Posted (Actual): March 8, 2017

Study Record Updates

• Last Update Posted (Actual): March 15, 2018
• Last Update Submitted That Met QC Criteria: March 14, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Ergocalciferols
• Other Study ID Numbers: F170216006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No