Vitamin D and Chronic Renal Insufficiency - Full Text View

Sponsor:	Odense University Hospital
Information provided by:	Odense University Hospital
ClinicalTrials.gov Identifier:	NCT00968877

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 III

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:

Genetics Home Reference related topics: carbamoyl phosphate synthetase I deficiency

MedlinePlus related topics: Kidney Failure Vitamin D

Drug Information available for: Cholecalciferol Vitamin D

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
Vitamin D Deficiency
Renal Insufficiency
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 February 09, 2012