Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Differential Effects of Ergocalciferol and Cholecalciferol Therapies in Chronic Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01835691
Recruitment Status : Completed
First Posted : April 19, 2013
Last Update Posted : October 19, 2017
Sponsor:
Information provided by (Responsible Party):
Jason Stubbs, MD, University of Kansas Medical Center

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) Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : October 2011
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change in total serum 25-hydroxyvitamin D [25(OH)D] levels (ng/mL) [ Time Frame: Baseline to immediately post-therapy (week 12) ]

Secondary Outcome Measures :
  1. Change in serum 25-hydroxyvitamin D2 and D3 subfractions (ng/mL) [ Time Frame: Baseline to immediately post-therapy (week 12), and week 12 to week 18 ]
  2. Change in total serum 25(OH)D (ng/mL) [ Time Frame: week 12 to week 18 ]
  3. Change in serum intact parathyroid hormone (PTH) (pg/mL) [ Time Frame: Baseline to week 12 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01835691


Locations
Layout table for location information
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Jason Stubbs, MD University of Kansas Medical Center

Layout table for additonal information
Responsible Party: Jason Stubbs, MD, Assistant Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT01835691     History of Changes
Other Study ID Numbers: 12861
First Posted: April 19, 2013    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: October 2017

Keywords provided by Jason Stubbs, MD, University of Kansas Medical Center:
Chronic Kidney Disease
Vitamin D
Vitamin D2
Vitamin D3

Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents