Vitamin D Deficiency Clinical Trial
Official title:
Vitamin D and Chronic Renal Insufficiency
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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