Cholecalciferol (Vitamin D3) Therapy in Chronic Kidney Disease (CKD) Subjects
Status:
Completed
Trial end date:
2013-03-01
Target enrollment:
Participant gender:
Summary
This is a 12 week pilot and feasibility study with an enrollment goal of 30 subjects. Half of
the subjects will be randomized to vitamin D3 and the other half will receive a placebo.
Subjects will be referred from the nutrition or renal clinic at Emory. CKD 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 or vitamin D analogues. Subjects will sign
an informed consent form after reviewing the protocol in detail with the principal
investigator. A questionnaire would collect information about dietary vitamin D intake,
sunlight exposure, and any symptoms of vitamin D deficiency. The subject will have baseline
levels of serum vitamin D (25-hydroxyvitamin D), parathyroid hormone (PTH), serum calcium and
phosphate, creatinine and other markers of bone turnover. The questionnaires and the blood
draws would be repeated on the 6th and 12th week of the study. Subjects will be given 12
pills of each containing either 50,000 IU vitamin D or placebo and asked to take one pill a
week. They would be scheduled to return to the clinic after 6 weeks and blood measurements
would be repeated. Subjects will be asked to revisit for their final visit at the 12th week
when they would have their last blood draw and assessment.
Phase:
N/A
Details
Lead Sponsor:
Atlanta VA Medical Center
Treatments:
Cholecalciferol Ergocalciferols Vitamin D Vitamins