N/A
N=9
Tumor Necrosis Factor Decreases Vitamin D Dependant Calcium Absorption
Rheumatoid Arthritis · Crohn's Disease
Bottom Line
View on ClinicalTrials.gov: NCT00427804 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Sep 2011
Primary outcome: Primary: Intestinal Absorption of Calcium
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- calcitriol (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Atlanta VA Medical Center
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intestinal Absorption of Calcium |
— | — |
| PRIMARY Fractional Absorption of Calcium |
71; 115 | — |
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.
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)
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.