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Vitamin D and Chronic Renal Insufficiency

Vitamin D and Chronic Renal Insufficiency

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00968877
Enrollment
56
Registered
2009-08-31
Start date
2009-09-30
Completion date
2011-01-31
Last updated
2011-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Renal Insufficiency, Vitamin D Deficiency

Keywords

Renal Insufficiency, Cholecalciferol, Kidney Disease, Kidney Failure, Vitamin D, Vitamin D Deficiency, Vitamin D3

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.

Interventions

DRUGCholecalciferol

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

Sponsors

Odense University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Calcium phosphate associated metabolites, bone markers, endothelial markers, inflammation muscle function, pulse wave velocity test8 weeks

Secondary

MeasureTime frame
Health questionnaire8 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026