Differential Effects of Ergocalciferol and Cholecalciferol Therapies in Chronic Kidney Disease

Sponsor

University of Kansas Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01835691

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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?

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease	Dietary Supplement: Vitamin D2 (ergocalciferol) Dietary Supplement: Vitamin D3 (cholecalciferol)	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

Differential Effects of Ergocalciferol and Cholecalciferol Therapies in Chronic Kidney Disease

Study Start Date :

Oct 1, 2011

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vitamin D2 (ergocalciferol) 50,000 units once a week for 12 weeks	Dietary Supplement: Vitamin D2 (ergocalciferol) 50,000 units once a week for 12 weeks
Experimental: Vitamin D3 (cholecalciferol) 50,000 units once a week for 12 weeks	Dietary Supplement: Vitamin D3 (cholecalciferol) 50,000 units once a week for 12 weeks

Arm

Intervention/Treatment

Experimental: Vitamin D2 (ergocalciferol)

50,000 units once a week for 12 weeks

Dietary Supplement: Vitamin D2 (ergocalciferol)

50,000 units once a week for 12 weeks

Experimental: Vitamin D3 (cholecalciferol)

50,000 units once a week for 12 weeks

Dietary Supplement: Vitamin D3 (cholecalciferol)

50,000 units once a week for 12 weeks

Outcome Measures

Primary Outcome Measures

Change in total serum 25-hydroxyvitamin D [25(OH)D] levels (ng/mL) [Baseline to immediately post-therapy (week 12)]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).