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Vitamin D as a Modifier of Serum Hepcidin in Children With Chronic Kidney Disease (D-fense)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Johns Hopkins University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Meredith Atkinson, MD, MHS, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01532349
First received: February 8, 2012
Last updated: September 19, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Anemia of Chronic Kidney Disease
Drug: Cholecalciferol
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cholecalciferol as a Modifier of Serum Hepcidin in Children With Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Change in serum hepcidin with vitamin D intervention for children with chronic kidney disease [ Time Frame: three months ] [ Designated as safety issue: No ]
    The null hypothesis to be tested is that Vitamin D supplementation will not be associated with a decrease in serum hepcidin over the study period. Statistical analysis will be performed as intention-to-treat.


Estimated Enrollment: 28
Study Start Date: May 2012
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 400 IU vitamin D
Children will be randomly allocated to receive cholecalciferol supplementation 400 IU/day (2,800 IU/weekly), which is the recommended dietary allowance. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.
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.
Other Names:
  • tablet: National Vitamin Company, Casa Grande, AZ
  • liquid: Enfamil® D-Vi-Sol™ Drops
Active Comparator: 4000 IU vitamin D
Children will be randomly allocated to receive cholecalciferol supplementation 4000 IU/day (28,000 IU weekly) according to the KDOQI recommended supplementation for children with mild 25D deficiency. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.
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.
Other Names:
  • tablet: National Vitamin Company, Casa Grande, AZ
  • liquid: Enfamil® D-Vi-Sol™ Drops

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Year to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of stage 2-5 Chronic Kidney Disease (estimated glomerular filtration rate [GFR] between 15 and < 90 ml/min/1.73m2) based on the new bedside Schwartz formula estimation using serum creatinine and height [height in cm x 0.413/serum creatinine]
  • 1-21 years of age
  • Willingness and ability to provide informed consent and assent

Exclusion Criteria:

  • Children less than 1 year of age (in whom risk of vitamin D toxicity may be increased) or greater than 21 years at time of study screening
  • Children with a documented history of hypercalcemia or nephrolithiasis
  • Children with GI tract discontinuity (ostomy)
  • Current pregnancy or pregnancy within the last 12 months
  • Children with known anemia-related disorders including sickle cell anemia, thalassemia
  • Children with severe 25D deficiency (< 5 ng/mL) likely to be associated with severe morbidity and requiring prompt high dose vitamin D supplementation, or with 25D levels > 60 ng/mL which could be associated with increased risk of vitamin D toxicity
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01532349

Contacts
Contact: Meredith Atkinson, MD 410-955-2467 matkins3@jhmi.edu
Contact: Sara Boynton 443-287-9051 sboynto3@jhmi.edu

Locations
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Meredith Atkinson    410-955-2467    matkins3@jhmi.edu   
Contact: Sara Boynton    443-287-9051    sboynto3@jhmi.edu   
Principal Investigator: Meredith Atkinson, MD, MHS         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Meredith Atkinson, MD, MHS Johns Hopkins University
  More Information

No publications provided

Responsible Party: Meredith Atkinson, MD, MHS, Assistant Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01532349     History of Changes
Other Study ID Numbers: NA_00066175, 1K23DK084116-01A2
Study First Received: February 8, 2012
Last Updated: September 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
chronic kidney disease
anemia

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014