Effectiveness of Vitamin D3 Therapy in
Correcting Vitamin D Insufficiency in Subjects
With Chronic Kidney Disease (NCT00427037)
by Mr. Pitonyak
Background:
Patients with Chronic Kidney Disease (CKD) often suffer from severe metabolic bone disease.
Most commonly, these disorders are caused by abnormalities of minerals such as calcium,
phosphorus, magnesium or vitamin D. Vitamin D is important for musculoskeletal health.
Vitamin D can be obtained from the diet or made in the skin from exposure to sunlight, but it has
to be converted by the kidneys into calcitriol (a form of Vitamin D), in order to be effective.
Decreased kidney function in CKD patients causes reduced capability to convert vitamin D into a
usable form called calcitriol. The current standard of care for patients with chronic renal (kidney)
disease is treatment with vitamin D drugs such as Rocaltrol or Hectoral. However, these
medications have the potential to cause elevated amounts of calcium in the blood.
Purpose:
To investigate the effectiveness and safety of cholecalciferol (vitamin D3) in raising blood serum
25-hydroxyvitamin D levels in CKD patients. If successful, this study would provide the
necessary preliminary data in order to conduct a larger study supplementing vitamin D in chronic
kidney disease patients. One potential area of study would be to see whether subjects
supplemented with vitamin D were able to raise their active vitamin D levels processed by the
kidneys compared to those subjects who were just supplemented with a placebo. This study is
necessary in order to determine whether weekly intake of a high dose vitamin D is sufficient to
decrease the parathyroid hormone levels in the given time frame
Description:
This was a 12 week randomized, placebo controlled pilot and feasibility study with an
enrollment of 34 subjects. Half of the subjects were be randomly chosen to take vitamin D3 and
the other half received a placebo. This was a double-blind study where neither the subjects or the
experimenter knerw if they are getting the Vitamin D or the placebo. Subjects were be referred
from the nutrition or renal clinic at Emory University. Chronic Kidney Disease stage 3 and 4
patients will be eligible for participation if they have been determined to have vitamin D
deficiency and are not on treatment with vitamin D. The subjects had baseline levels of serum
vitamin D (25-hydroxyvitamin D), blood serum calcium, phosphate, creatinine and other markers
of kidney function. The questionnaires and the blood draws were repeated on the 6th and 12th
week of the study. Subjects were be given 12 pills of each containing either 50,000 IU vitamin D
or placebo and asked to take one pill a week. They returned to the clinic after 6 weeks and blood
measurements were repeated. Subjects were asked to revisit the clinic for their final visit at the
12th week when they had their last blood draw and assessment.
Conclusion:
This study was updated on February 11, 2009. It showed that weekly cholecalciferol( Vitamin
D3 50,000 IU) supplementation appears to be an effective treatment to correct vitamin D status
in patients with Chronic Kidney Disease