Tumor Necrosis Factor Decreases Vitamin D Dependant Calcium Absorption

Completed · Not applicable

Conditions studied: Rheumatoid Arthritis, Crohn's Disease

In brief

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.

Key facts

Study ID

NCT00427804

Run by

Atlanta VA Medical Center

People needed

9

Starts

2007-01-01

Expected to finish

2009-11-01

Last updated by the study team

2013-02-04

Who can join

Age: 18 and older, up to 50. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Males
• Age 18 to 50
• History of Crohn's disease or Rheumatoid Arthritis (cases) or healthy individuals (controls)

You may not qualify if…

• 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)

Where it is running

• Atlanta VAMC — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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