Cholecalciferol (Vitamin D3) Therapy in Chronic Kidney Disease (CKD) Subjects

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Atlanta VA Medical Center
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• Age 18-85

• CKD stage 3-4 (GFR 15-59 ml/min/1.73 m2 body surface area, calculated by using the MDRD Study equation GFR Calculator)

• serum 25(OH)D concentrations ≤ 30 ng/mL, and serum PTH levels >70 pg/mL documented within the last six months

Exclusion Criteria:

• History of liver failure (serum AST or ALT > 3-fold the upper limit of normal)

• requiring dialysis at any stage of the study

• history of intestinal malabsorption or chronic diarrhea

• serum calcium level (corrected for serum albumin) > 10.5 mg/dL

• calcium x phosphorus product >70

• treatment with more than 1000 IU of vitamin D per day, or current treatment with a vitamin D analogue or calcimimetic

• an anti-epileptic medication and other medications which can affect vitamin D metabolism (e.g., phenobarbital, phenytoin, rifampicin)