Randomized Study of Two Vitamin D Dosing Strategies in Children With Chronic Kidney Disease
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 9 - 19 |
| Updated: | 7/20/2018 |
| Start Date: | September 2014 |
| End Date: | June 2020 |
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.
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.
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.
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