Two Vitamin D Dosing Strategies in Children With Chronic Kidney Disease
Completed · Phase 1
Conditions studied: Chronic Kidney Disease
In brief
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 kidney disease. To date, several studies using different doses of vitamin D have been tried to correct vitamin D deficiency, but none has been completely successful. The investigators are comparing two different doses of vitamin D to determine which one is more effective at correcting and maintaining normal blood levels of vitamin D. The investigators hypothesize that a higher percentage of children receiving a higher dose of vitamin D will be vitamin D replete at the end of 6 months. This study will enroll 80 children 9 to 18 years old who have chronic kidney disease (CKD) and can take pills. They will be enrolled from Chronic Renal Insufficiency Clinic, the Hemodialysis Unit, Peritoneal Dialysis Clinic and Transplant Clinic at Children's Healthcare of Atlanta.
Key facts
- Study ID
- NCT01909115
- Run by
- Emory University
- People needed
- 98
- Starts
- 2013-09-01
- Expected to finish
- 2014-09-26
- Last updated by the study team
- 2020-05-19
Who can join
Age: 9 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Childen's Healthcare of Atlanta — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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