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OpenTrials
Completed

NCT Number: NCT01835691

Differential Effects of Ergocalciferol and Cholecalciferol Therapies in Chronic Kidney Disease

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?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Vitamin D2 (Ergocalciferol)

Dietary Supplement

50,000 units once a week for 12 weeks

vitamin D3 (cholecalciferol)

Dietary Supplement

50,000 units once a week for 12 weeks

Primary outcomes

  1. Change in total serum 25-hydroxyvitamin D [25(OH)D] levels (ng/mL)

    Time frame: Baseline to immediately post-therapy (week 12)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Apr 19, 2013
Registry last updated
Oct 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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