Chronic Kidney Disease
Conditions
Keywords
Chronic Kidney Disease, Vitamin D, Vitamin D2, Vitamin D3
Brief summary
This study is to research two questions. First, is vitamin D3 more effective than vitamin D2 in raising 25-hydroxyvitamin D \[25(OH)D\] levels in chronic kidney disease (CKD) patients? And secondly, what are the differential effects of vitamin D2 and vitamin D3 on other mineral metabolism parameters?
Detailed description
Vitamin D helps form and strengthens bones by allowing the body to absorb calcium. Vitamin D helps the immune system fight infection as well as helps keep muscles strong. Without enough vitamin D, bones can become weak, thin and brittle. Vitamin D is useful in people with various types of health issues. Patients with CKD exhibit an unusually high rate of vitamin D deficiency, which may contribute to some of the poor clinical outcomes in this group. This study will randomize patients with CKD and low vitamin D levels to two groups; one group will be treated with vitamin D2 (ergocalciferol) and the other group will be treated with vitamin D3 (cholecalciferol). The purpose of this study is to compare the effects of the two different forms of vitamin D specifically in patients chronic kidney disease.
Interventions
DIETARY_SUPPLEMENTVitamin D2 (ergocalciferol)
50,000 units once a week for 12 weeks
DIETARY_SUPPLEMENTVitamin D3 (cholecalciferol)
50,000 units once a week for 12 weeks
Sponsors
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 and above * Chronic kidney disease with an estimated glomerular filtration rate (GFR) between 15-60 ml/min (CKD stage III-IV) * Vitamin D insufficiency (25-hydroxyvitamin D level \< 30 ng/mL) that has not been treated with vitamin D replacement since the acquisition of this level
Exclusion criteria
* Current treatment with cholestyramine * Presence of GI disorders such as short bowel, history of gastrectomy, colectomy, gastric bypass, inflammatory bowel disease, celiac disease, disorders of fat absorption, chronic diarrhea. * Liver cirrhosis * Known current substance abuse * Current treatment with immunosuppressant medications * Presence of chronic infection * History of chronic inflammatory disease (i.e. - lupus, active rheumatoid arthritis, Crohns disease) * Currently receiving high-dose vitamin D replacement (avg dose of ≥ 3,000 U per day) or active vitamin D analogue (e.g., calcitriol, which is 1,25-dihydroxyvitamin vitamin D).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in total serum 25-hydroxyvitamin D [25(OH)D] levels (ng/mL) | Baseline to immediately post-therapy (week 12) |
Secondary
| Measure | Time frame |
|---|---|
| Change in serum 25-hydroxyvitamin D2 and D3 subfractions (ng/mL) | Baseline to immediately post-therapy (week 12), and week 12 to week 18 |
| Change in total serum 25(OH)D (ng/mL) | week 12 to week 18 |
| Change in serum intact parathyroid hormone (PTH) (pg/mL) | Baseline to week 12 |
Countries
United States
Outcome results
None listed