Vitamin D as a Modifier of Serum Hepcidin in Children With Chronic Kidney Disease (D-fense)
This study is not yet open for participant recruitment.
Verified February 2012 by Johns Hopkins University
Sponsor:
Johns Hopkins University
Collaborator:
Information provided by (Responsible Party):
Meredith Atkinson, MD, MHS, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01532349
First received: February 8, 2012
Last updated: February 9, 2012
Last verified: February 2012
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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 diesease [ 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 |
| 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:
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|
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:
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01532349
Contacts
| Contact: Kari Bass | 443-287-9043 | kbass3@jhmi.edu |
| Contact: Sara Boynton | 443-287-9051 | sboynto3@jhmi.edu |
Locations
| United States, Maryland | |
| Johns Hopkins University | Not yet recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: Kari Bass 443-287-9043 kbass3@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: | February 9, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Johns Hopkins University:
|
chronic kidney disease anemia |
Additional relevant MeSH terms:
|
Anemia Kidney Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic Hematologic Diseases Urologic Diseases Renal Insufficiency Cholecalciferol |
Vitamin D Ergocalciferols Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on May 21, 2013