Vitamin D and Chronic Renal Insufficiency

NCT ID: NCT00968877

Last Updated: 2011-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-01-31

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.

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.

Conditions

Vitamin D Deficiency; Chronic Renal Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Cholecalciferol

Group Type: ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type: DRUG

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

Placebo

Group Type: PLACEBO_COMPARATOR

Cholecalciferol

Intervention Type: DRUG

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

Interventions

Cholecalciferol

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

Intervention Type: DRUG

Other Intervention Names

Dekristol

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Peter Marckmann

Principal Investigators

Peter Marckmann, Prof, DMSc

Role: STUDY_DIRECTOR

Nephrological department, Odense University Hospital

Other Identifiers

Vita-D3

Identifier Type: -

Identifier Source: org_study_id