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Differential Effects of Ergocalciferol and Cholecalciferol Therapies in Chronic Kidney Disease

NCT ID: NCT01835691

Last Updated: 2017-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-06-30

Brief Summary

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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

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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.

Conditions

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Chronic Kidney Disease

Keywords

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Chronic Kidney Disease Vitamin D Vitamin D2 Vitamin D3

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Vitamin D2 (ergocalciferol)

50,000 units once a week for 12 weeks

Group Type EXPERIMENTAL

Vitamin D2 (ergocalciferol)

Intervention Type DIETARY_SUPPLEMENT

50,000 units once a week for 12 weeks

Vitamin D3 (cholecalciferol)

50,000 units once a week for 12 weeks

Group Type EXPERIMENTAL

Vitamin D3 (cholecalciferol)

Intervention Type DIETARY_SUPPLEMENT

50,000 units once a week for 12 weeks

Interventions

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Vitamin D2 (ergocalciferol)

50,000 units once a week for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Vitamin D3 (cholecalciferol)

50,000 units once a week for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jason Stubbs, MD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jason Stubbs, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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12861

Identifier Type: -

Identifier Source: org_study_id