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Vitamin D and Chronic Renal Insufficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00968877
Recruitment Status : Completed
First Posted : August 31, 2009
Last Update Posted : January 26, 2011
Sponsor:
Information provided by:
Odense University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Vitamin D Deficiency Chronic Renal Insufficiency Drug: Cholecalciferol Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Vitamin D and Chronic Renal Insufficiency
Study Start Date : September 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Calcium phosphate associated metabolites, bone markers, endothelial markers, inflammation muscle function, pulse wave velocity test [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Health questionnaire [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00968877


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

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Responsible Party: Nephrological department, Peter Marckmann
ClinicalTrials.gov Identifier: NCT00968877    
Other Study ID Numbers: Vita-D3
First Posted: August 31, 2009    Key Record Dates
Last Update Posted: January 26, 2011
Last Verified: December 2009
Keywords provided by Odense University Hospital:
Renal Insufficiency
Cholecalciferol
Kidney Disease
Kidney Failure
Vitamin D
Vitamin D Deficiency
Vitamin D3
Additional relevant MeSH terms:
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Renal Insufficiency
Renal Insufficiency, Chronic
Vitamin D Deficiency
Kidney Diseases
Urologic Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents