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

Primary Purpose

CKD, Chronic Kidney Diseases, Hepcidin

Status

Withdrawn

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Ergocalciferol 50000 UNT

Placebo

About this trial

This is an interventional treatment trial for CKD

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Oral Ergocalciferol

Placebo

Arm Description

Oral Ergocalciferol 50000 IU once daily for 6 weeks

Outcomes

Primary Outcome Measures

Change in serum hepcidin levels

Difference in change in serum hepcidin levels (ng/ml) over time between the two groups

Secondary Outcome Measures

Change in serum hemoglobin level

Difference in change in serum hemoglobin levels (g/dL) over time between the two groups

Change in serum ferritin level

Difference in change in serum ferritin levels (ng/ml) over time between the two groups

Change in percent transferrin saturation

Difference in change in percent transferrin saturation (%) over time between the two groups

Change in serum iron level

Difference in change in serum iron levels (mcg/dL) over time between the two groups

Full Information

NCT ID

NCT03073369

First Posted

February 28, 2017

Last Updated

March 14, 2018

Sponsor

University of Alabama at Birmingham

Collaborators

American Heart Association

1. Study Identification

Unique Protocol Identification Number

NCT03073369

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Withdrawn

Why Stopped

Study didn't materialize for various reasons.

Study Start Date

January 1, 2018 (Anticipated)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Alabama at Birmingham

Collaborators

American Heart Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oral Ergocalciferol

Arm Type

Active Comparator

Arm Description

Oral Ergocalciferol 50000 IU once daily for 6 weeks

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Ergocalciferol 50000 UNT

Intervention Description

Oral Ergocalciferol 50000 IU once daily for 6 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral Placebo - one capsule once daily for 6 weeks

Primary Outcome Measure Information:

Title

Change in serum hepcidin levels

Description

Difference in change in serum hepcidin levels (ng/ml) over time between the two groups

Time Frame

At Day 0, Day 3, 1 week, 4 weeks and 6 weeks

Secondary Outcome Measure Information:

Title

Change in serum hemoglobin level

Description

Difference in change in serum hemoglobin levels (g/dL) over time between the two groups

Time Frame

At Day 0, Day 3, 1 week, 4 weeks and 6 weeks

Title

Change in serum ferritin level

Description

Difference in change in serum ferritin levels (ng/ml) over time between the two groups

Time Frame

At Day 0, Day 3, 1 week, 4 weeks and 6 weeks

Title

Change in percent transferrin saturation

Description

Difference in change in percent transferrin saturation (%) over time between the two groups

Time Frame

At Day 0, Day 3, 1 week, 4 weeks and 6 weeks

Title

Change in serum iron level

Description

Difference in change in serum iron levels (mcg/dL) over time between the two groups

Time Frame

At Day 0, Day 3, 1 week, 4 weeks and 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

University of Alabama at Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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