Cholecalciferol (Vitamin D3) Therapy in Chronic Kidney Disease (CKD) Subjects
Condition: Chronic Kidney Disease; Vitamin D Deficiency
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Vitamin D Deficiency
Study type: Interventional

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.
    

Detailed description: 
      Vitamin D supplementation in reducing secondary hyperparathyroidism in chronic kidney disease
      patients, stage 3 and 4: A randomized, placebo controlled pilot study Problem of interest
      Chronic Kidney Disease (CKD) patients suffer from severe metabolic bone disease, which
      represents a formidable challenge to physicians. Defective vitamin D metabolism, and
      secondary parathyroid activation have been suggested as possible causes. 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,
      the active form in order to be effective. Decreased kidney mass in CKD patients causes
      reduced capability to convert vitamin D into calcitriol due to less 1-alpha hydroxylase
      enzyme levels. Current standard of care for patients with chronic renal disease is treatment
      with vitamin D analogues such as Rocaltrol or Hectoral. However, these medications have the
      potential to cause hypercalcemia. Studies have shown that calcitriol production becoming
      dependent on 25- hydroxyvitamin D availability in moderate CKD patients. There is speculation
      that there is still some "reserve" left for the generation of calcitriol from vitamin D in
      these patients.

      The main question being posed in this study is:

      Primary: Can a weekly high dose supplementation of cholecalciferol be effective in raising
      25(OH)D levels in patients with CKD and can this reduce parathyroid hormone levels in
      pre-dialysis chronic kidney disease patients?

      Study Design This is an 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 D3 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.

      Treatment This is a randomized control trial. Only half of the subjects will receive vitamin
      D treatment and the other half placebo. If at the end of the study, the subject is still
      vitamin D deficiency, they will be referred to an endocrinologist or to their primary doctor
      for treatment.

      Scientific advancement If successful, this study would provide the necessary preliminary data
      in order to conduct a larger randomized controlled 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 using the
      "reserve" hydroxylase enzyme in 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.
    

Intervention name(s): Cholecalciferol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50,000 IU weekly by mouth; identical placebo pill orally by mouth
Other intervention name(s): Vitamin D3 is cholecalciferol; D3
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Vitamin D deficiency; Chronic Kidney Disease