Differential Effects of Ergocalciferol and Cholecalciferol Therapies in Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

Official title:

Differential Effects of Ergocalciferol and Cholecalciferol Therapies in Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01835691
• Other study ID #: 12861
• Status: Completed
• Phase: N/A
• First received: April 12, 2013
• Last updated: October 17, 2017
• Start date: October 2011
• Est. completion date: June 2015

Study information

• Verified date: October 2017
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• Vitamin D2 (ergocalciferol)
50,000 units once a week for 12 weeks
• Vitamin D3 (cholecalciferol)
50,000 units once a week for 12 weeks

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in total serum 25-hydroxyvitamin D [25(OH)D] levels (ng/mL)		Baseline to immediately post-therapy (week 12)
Secondary	Change in serum 25-hydroxyvitamin D2 and D3 subfractions (ng/mL)		Baseline to immediately post-therapy (week 12), and week 12 to week 18
Secondary	Change in total serum 25(OH)D (ng/mL)		week 12 to week 18
Secondary	Change in serum intact parathyroid hormone (PTH) (pg/mL)		Baseline to week 12