Tumor Necrosis Factor Decreases Vitamin D Dependant Calcium Absorption

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: Male

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 to normal controls. This initial pilot study is being done to determine if it is feasible to conduct a study where TNFα could be blocked (e.g., by anti-TNFα therapy such as Enbrel® or Remicade®) to improve vitamin D dependant calcium absorption and thus bone health.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Atlanta VA Medical Center
• Collaborator: Emory University
• Treatments: Calcitriol; Calcium, Dietary; Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• Males

• Age 18 to 50

• History of Crohn's disease or Rheumatoid Arthritis (cases) or healthy individuals (controls)

Exclusion Criteria:

• 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)