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Vitamin D and Chronic Renal Insufficiency

This study has been completed.
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00968877
First received: August 28, 2009
Last updated: January 25, 2011
Last verified: December 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Vitamin D Deficiency
Chronic Renal Insufficiency
 Drug: Cholecalciferol
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Vitamin D and Chronic Renal Insufficiency

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Calcium phosphate associated metabolites, bone markers, endothelial markers, inflammation muscle function, pulse wave velocity test [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Health questionnaire [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: September 2009
Study Completion Date: January 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cholecalciferol Drug: Cholecalciferol
capsule 40 000 IU (p.o.) once per week, in 8 weeks.
Other Name: Dekristol
Placebo Comparator: Placebo Drug: Cholecalciferol
capsule 40 000 IU (p.o.) once per week, in 8 weeks.
Other Name: Dekristol

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00968877

Sponsors and Collaborators
Odense University Hospital
Investigators
Study Director: Peter Marckmann, Prof, DMSc Nephrological department, Odense University Hospital
  More Information

No publications provided

Responsible Party: Nephrological department, Peter Marckmann
ClinicalTrials.gov Identifier: NCT00968877     History of Changes
Other Study ID Numbers: Vita-D3
Study First Received: August 28, 2009
Last Updated: January 25, 2011
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency

Keywords provided by Odense University Hospital:
Renal Insufficiency
Cholecalciferol
Kidney Disease
Kidney Failure
 Vitamin D
Vitamin D Deficiency
Vitamin D3

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Vitamin D Deficiency
Kidney Diseases
Urologic Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
 Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 22, 2013