Effects of Vitamin D Replacement on Hormones Regulating Iron Metabolism in Individuals With Chronic Kidney Disease

NCT01988116 | Completed Early Phase 1 DMC

• 1 other identifier: F130725013
• Study Type: interventional
• Target: 40
• 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 two hormones that control iron levels, hepcidin and hemojuvelin 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. Another protein, known as 'hemojuvelin', has been recently discovered and is also thought to control the amount of iron in the blood. The relationship between vitamin D and hemojuvelin has never been studied before. In this study, investigators would like to examine the effects of vitamin D on iron metabolism and blood levels of hepcidin C and hemojuvelin in individuals with CKD.

Conditions

Chronic Kidney Disease; Anemia of Chronic Disease

Keywords

Chronic kidney disease; Anemia of chronic disease; Iron Metabolism; Iron Homeostasis; Vitamin D; Calcitriol; hemojuvelin; hepcidin; anemia; ferroportin

Outcome Measures

Primary Outcomes (3)

• Change in serum hepcidin levels

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

• Change in soluble hemojuvelin

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

• Change in other indices of iron metabolism

  Including, Serum Ferritin, Iron level, Percent transferrin saturation and TIBC

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

Secondary Outcomes (1)

• Change in serum hemoglobin

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

Study Arms (2)

Oral Calcitriol

EXPERIMENTAL

Oral Calcitriol 0.5 mcg once daily for 6 weeks

Drug: Oral Calcitriol 0.5 mcg once daily for 6 weeks

Placebo Arm

PLACEBO COMPARATOR

Placebo capsule 1 Capsule once daily for 6 weeks

Drug: Placebo

Interventions

Oral Calcitriol 0.5 mcg once daily for 6 weeks DRUG

Also known as: Rocaltrol

Oral Calcitriol

Placebo DRUG

Placebo Arm

Eligibility Criteria

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

You may qualify if:

• Patients with mild to moderate CKD (eGFR 15 - 60 ml/min/1.73 m2) as estimated by the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula.

You may not qualify if:

• Subjects currently receiving active vitamin D analog therapy or history of recent (\< 3 months) use.
• Subjects currently receiving nutritional vitamin D (cholecalciferol or ergocalciferol) in dosages greater than 2000 IU/day.
• Subjects receiving erythropoiesis stimulating agents.
• Subjects receiving intravenous iron therapy.
• Subjects receiving oral iron therapy started within 3 months prior to recruitment.
• Subjects with severe anemia defined as Hb \< 8.0 g/dL for males and Hb \<7.0 g/dL for females.
• Subjects with iron deficiency anemia defined as serum ferritin \<100ng/ml and Transferring Saturation \< 20%.
• Pregnancy and lactation.
• Subjects with hypercalcemia defined as serum calcium level of \> 10.0 mg/dL.
• Subjects with serum phosphorus concentration of \> 4.5 mg/dL.
• Subjects with acute kidney injury or rapidly declining GFR.
• Subjects receiving any form of renal replacement therapy including hemodialysis, peritoneal dialysis, and patients with renal transplant.
• Subjects with focus of active inflammation or infection determined clinically.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• Panwar B, McCann D, Olbina G, Westerman M, Gutierrez OM. Effect of calcitriol on serum hepcidin in individuals with chronic kidney disease: a randomized controlled trial. BMC Nephrol. 2018 Feb 9;19(1):35. doi: 10.1186/s12882-018-0823-7.

  PMID: 29426300 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Anemia

Interventions

Calcitriol

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; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Bhupesh Panwar, MD

  University of Alabama, Nephrology Division

  PRINCIPAL INVESTIGATOR

• Orlando M Gutierrez, MD,MMSc

  University of Alabama, Nephrology Division

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 20, 2013
• Study Start: October 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: August 24, 2015

Record last verified: 2015-08

Locations

US (1)