Status:
COMPLETED
Two Vitamin D Dosing Strategies in Children With Chronic Kidney Disease
Lead Sponsor:
Emory University
Collaborating Sponsors:
Children's Healthcare of Atlanta
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
9-21 years
Phase:
PHASE1
Brief Summary
Vitamin D deficiency is common in the general population and more common in children with chronic kidney disease. Vitamin D is very important for bone health, especially in children with chronic kidne...
Detailed Description
Vitamin D has a critical role in bone metabolism. In addition, there is increasing evidence that vitamin D has an important role in many other areas, including cardiovascular health, immune function, ...
Eligibility Criteria
Inclusion
- Patient's parent/legal guardian must be willing and able to give written informed consent and the patient must be willing to give written informed assent if applicable
- Estimated glomerular filtration rate \< 60 mL/min/1.73 m2 body surface area or recipient of a kidney transplant
- 9-21 years old
- Able to swallow pills
Exclusion
- Liver failure
- Malabsorption
- Current calcium level \>10.5 mg/dL
- History of hypercalcemia (Ca \>11 mg/dL) during the preceding 6 months
- Current treatment with an antiepileptic drug or other medications that may affect vitamin D metabolism (e.g., phenobarbital, phenytoin, rifampicin)
- History of hypervitaminosis D
- Completion of a course of high dose vitamin D within the preceding 2 months
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2014
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT01909115
Start Date
September 1 2013
End Date
September 26 2014
Last Update
May 19 2020
Active Locations (1)
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1
Childen's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322