Two Vitamin D Dosing Strategies in Children With Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

Official title:

Randomized Trial of Two Maintenance Doses of Vitamin D and Trace Element Status in Children With Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01909115
• Other study ID #: IRB00067067
• Secondary ID: EmoryPedNeph-001
• Status: Completed
• Phase: Phase 1
• Start date: September 2013
• Est. completion date: September 26, 2014

Study information

• Verified date: May 2020
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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, and prevention of autoimmune diseases and certain malignancies. In patients with CKD, there are a variety of abnormalities in mineral metabolism that lead to bone disease.

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). Participants will take vitamin D capsules every day for 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: September 26, 2014
• Est. primary completion date: September 26, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 21 Years

Eligibility

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. 9-21 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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• 1000 IU of Vitamin D3
1000 IU of Vitamin D will be administered in capsule form, once daily.
• 4000 IU of Vitamin D3
4000 IU of Vitamin D will be administered in capsule form, once daily.

Locations

Country	Name	City	State
United States	Childen's Healthcare of Atlanta	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Children's Healthcare of Atlanta

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Adequate Vitamin D Level	Vitamin D sufficiency will be assessed as the percentage of participants with a vitamin D level >30 ng/ml.	Month 6