Status:
COMPLETED
Tumor Necrosis Factor Decreases Vitamin D Dependant Calcium Absorption
Lead Sponsor:
Atlanta VA Medical Center
Collaborating Sponsors:
Emory University
Conditions:
Rheumatoid Arthritis
Crohn's Disease
Eligibility:
MALE
18-50 years
Phase:
NA
Brief Summary
This study is a pilot study to determine whether patients with TNFα excess have decreased calcium absorption in response to calcitriol (1,25-dihydroxyvitamin D, the active form of vitamin D) compared ...
Detailed Description
Vitamin D is important for the maintenance of normal calcium homeostasis by improving the efficacy of calcium absorption from the small intestine. The efficacy of calcium absorption is decreased with ...
Eligibility Criteria
Inclusion
- Males
- Age 18 to 50
- History of Crohn's disease or Rheumatoid Arthritis (cases) or healthy individuals (controls)
Exclusion
- Subjects already taking activated vitamin D medications such as calcitriol, Zemplar®, Hectoral®
- Vitamin D deficiency defined as 25(OH)D ≤ 20 ng/ml
- Post-menopausal women (absence of menses for greater than 6 months by history or FSH level \>20)
- History of nephrolithiasis
- History of hypercalcemia or hypercalciuria
- Short bowel disease
- Glucocorticoid use
- Use of osteoporosis medication (bisphosphonate, calcitonin or teriparatide)
- Chronic kidney disease (calculated GFR \<60 ml/min/1.73 m2)
- History of hyperparathyroidism (PTH greater than upper limit of normal) or
- Hypoparathyroidism (PTH below lower limit of normal)
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00427804
Start Date
January 1 2007
End Date
November 1 2009
Last Update
February 4 2013
Active Locations (1)
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1
Atlanta VAMC
Atlanta, Georgia, United States, 30030