N/A Completed N=9 Treatment

Tumor Necrosis Factor Decreases Vitamin D Dependant Calcium Absorption

Rheumatoid Arthritis · Crohn's Disease

Source: ClinicalTrials.gov NCT00427804 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2011

Primary outcomePrimary: Intestinal Absorption of Calcium

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Intestinal Absorption of Calcium	—	—
PRIMARY Fractional Absorption of Calcium	71; 115	—

Eligibility 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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00427804). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.