drugset / Trial / NCT01909115

Two Vitamin D Dosing Strategies in Children With Chronic Kidney Disease

NCT01909115

RandomizedParallel-groupQuadruple-blindTreatment

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 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.

Timeline

Start
2013-09
Primary completion
2014-09-26
Completion
2014-09-26

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cholecalciferol Other / unclassified 1000 iu Oral
Comparator Cholecalciferol Other / unclassified 4000 iu Oral