Skip to main content
OpenTrials
Completed

NCT Number: NCT00968877

Vitamin D and Chronic Renal Insufficiency

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Cholecalciferol

Drug

capsule 40 000 IU (p.o.) once per week, in 8 weeks.

Other names: Dekristol

Primary outcomes

  1. Calcium phosphate associated metabolites, bone markers, endothelial markers, inflammation muscle function, pulse wave velocity test

    Time frame: 8 weeks

Secondary outcomes

  1. Health questionnaire

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2011
First posted
Aug 31, 2009
Registry last updated
Jan 26, 2011

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.

Published trials that share one or more normalized conditions with this study.