MedTrace Logo

Vitamin D as a Modifier of Serum Hepcidin in Children With Chronic Kidney Disease

NCT01532349 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2017-06-14

Study results available
· View outcomes & findings →

Summary

This research is being done to study the effectiveness of vitamin D (cholecalciferol) to modify hepcidin levels in children with chronic kidney disease (CKD). Anemia is a common problem in children with CKD. Anemia is when the body does not have enough healthy red blood cells. Hepcidin is a protein in the blood which interferes with the body's production of red blood cells. This study will see if vitamin D lowers hepcidin levels in children and young adults with CKD. If so, it could be used as an additional treatment for anemia in these children, in addition to the current therapies already in use including iron supplements and erythropoietin. People between the ages of 1 and 21 with CKD may be considered for this study.

Conditions

  • Anemia of Chronic Kidney Disease

Interventions

DRUG

Cholecalciferol

Children will be randomly allocated to receive either cholecalciferol supplementation 4000 IU per day 400 IU/day. We are proposing a supplementation dose of 4000 IU/day in children with CKD, which is considered a safe dose by KDOQI standards; vitamin D2 doses as high as 10,000 IU/day have been given to French patients with CKD for \> 1 year with no evidence of vitamin D toxicity. Cholecalciferol will be provided in both tablet and liquid form, based on the ability to tolerate and preference of the subject. Participants will be monitored for signs of 25D toxicity (hypercalcemia, hyperphosphatemia, hypercalciuria) during the follow up period of 1 month and 3 months from baseline.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Meredith Atkinson, MD, MHS · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01532349 on ClinicalTrials.gov