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

NCT03073369 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: F170216006
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in serum hemoglobin level

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

• Change in serum ferritin level

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

• Change in percent transferrin saturation

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

• Change in serum iron level

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

Study Arms (2)

Oral Ergocalciferol

ACTIVE COMPARATOR

Oral Ergocalciferol 50000 IU once daily for 6 weeks

Drug: Ergocalciferol 50000 UNT

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ergocalciferol 50000 UNT DRUG

Oral Ergocalciferol 50000 IU once daily for 6 weeks

Oral Ergocalciferol

Placebo DRUG

Oral Placebo - one capsule once daily for 6 weeks

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• American Heart Association: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Anemia, Iron-Deficiency; Anemia

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Anemia, Hypochromic; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 8, 2017
• Study Start: January 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 15, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)