Randomized Study of Two Vitamin D Dosing Strategies in Children With Chronic Kidney Disease
This trial is active, not recruiting.
|Condition||chronic kidney disease|
|Start date||September 2013|
|End date||November 2014|
|Trial size||80 participants|
|Trial identifier||NCT01909115, EmoryPedNeph-001, IRB00067067|
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 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.
After the investigators obtain informed consent and assent, children will be randomly assigned to either low dose (1000 units daily) or high dose (4000 units daily) vitamin D pills (50% in each group). Patients will be in this study for 6 months. They will take vitamin D pills for 6 months. Vitamin D levels will be obtained at baseline, 3 months and 6 months. The study visits will be at the same time as routine clinic visits when the children are having blood drawn for routine care. At the end of the study, the investigators will compare the percentage of patients who have normal vitamin D levels at 6 months in the two groups. The investigators will also describe the percentage of patients who have elevated or low levels of trace elements.
The two doses of vitamin D in this study are within the dosing range recommended by the Institute of Medicine, and thus the investigators do not anticipate any adverse effects. Vitamin D toxicity could theoretically occur, and an elevated vitamin D level at 3 months would be an indication to withdraw a patient from the study.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Vitamin D capsule 1000 IU
Vitamin D capsule 4000 IU
Vitamin D sufficiency
time frame: 6 months
Male or female participants from 9 years up to 19 years old.
Inclusion Criteria: 1. 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. 2. Estimated glomerular filtration rate < 60 mL/min/1.73 m2 body surface area or recipient of a kidney transplant 3. 9-19 years old 4. Able to swallow pills Exclusion Criteria: 1. Liver failure 2. Malabsorption 3. Current calcium level >10.5 mg/dL 4. History of hypercalcemia (Ca >11 mg/dL) during the preceding 6 months 5. Current treatment with an antiepileptic drug or other medications that may affect vitamin D metabolism (e.g., phenobarbital, phenytoin, rifampicin). 6. History of hypervitaminosis D 7. Completion of a course of high dose vitamin D within the preceding 2 months.
|Official title||Randomized Study of Two Vitamin D Dosing Strategies in Children With Chronic Kidney Disease|
|Principal investigator||Larry Greenbaum, MD, PhD|
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