Vitamin D and Chronic Renal Insufficiency

January 25, 2011 updated by: Odense University Hospital
Purpose of this study is to investigate the effect of treatment with vitamin D3 (cholecalciferol) compared with placebo in a trial including chronic kidney disease patients with vitamin D deficiency.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Most patients with chronic renal insufficiency have vitamin D deficiency. It is still not common practice among nephrologists to monitor and correct vitamin D deficiency of chronic kidney disease (CKD) patients, because it is widely believed that any vitamin D deficiency associated with calcium-phosphate disturbances is better treated with activated vitamin D.

However, correction of vitamin D deficiency with native vitamin D seems to have numerous favorable effects not only related to the renal and intestinal handling of calcium and phosphate. It may have beneficial effects on bone and vascular health, the immune system and physical performance that are not obtained with active vitamin D treatment.

We are therefore planning a randomized, placebo-controlled, intervention study of 8 weeks' duration in which vitamin D3 supplementation (40 000 IE per week in one capsule) is compared with placebo in a trial including 120 CKD patients with vitamin D deficiency. Multiple biological variables are monitored in order to assess any effect on the biological systems of interest.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic kidney disease (CKD 3-5 amd renal transplanted patients)
  • Age > 18 years
  • Vitamin D insufficiency or deficiency (25-OHD < 50 nmol/l, 3 months before project start)

Exclusion Criteria:

  • Treatment with vitamin D2/D3 (dose more than 10000 IU within the last 3 months)
  • Hypercalcaemia (ca++ > 1,35 mmol/l more than 4 weeks despite missing intake of calcium containing preparations and activated vitamin D)
  • Uncontrolled hyperphosphataemia (s-phosphate > 2,2 mmol/l)
  • Sarcoidosis
  • Malignant disease
  • Psychotic disorders
  • Pregnancy and lactation women
  • Allergy to soya and peanut

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Cholecalciferol
capsule 40 000 IU (p.o.) once per week, in 8 weeks.
Other Names:
  • Dekristol
Active Comparator: Cholecalciferol
Drug: Cholecalciferol
capsule 40 000 IU (p.o.) once per week, in 8 weeks.
Other Names:
  • Dekristol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Calcium phosphate associated metabolites, bone markers, endothelial markers, inflammation muscle function, pulse wave velocity test
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Health questionnaire
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Investigators

  • Study Director: Peter Marckmann, Prof, DMSc, Nephrological department, Odense University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

August 28, 2009

First Submitted That Met QC Criteria

August 28, 2009

First Posted (Estimate)

August 31, 2009

Study Record Updates

Last Update Posted (Estimate)

January 26, 2011

Last Update Submitted That Met QC Criteria

January 25, 2011

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vita-D3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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