Clinical trial · Interventional
Tumor Necrosis Factor Decreases Vitamin D Dependant Calcium Absorption
Tumor Necrosis Factor-α Induces Vitamin D Resistance in Small Intestinal Calcium Absorption
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Crohn's Disease | — | UNRESOLVED | — |
| Rheumatoid Arthritis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| calcitriol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Calcitriol
- description
- Calcitriol 0.25 mcg orally twice a day for 7 days or calcitriol 0.50 mcg orally twice a day for 7 days.
- interventionNames
- Drug: calcitriol
Primary outcomes (2)
- measure
- Intestinal Absorption of Calcium
- timeFrame
- 12 Weeks
- measure
- Fractional Absorption of Calcium
- timeFrame
- 7 week
- description
- Fractional absorption of calcium (see citation for complete details)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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)
References
Publications (1)
- RESULTKumari M, Khazai NB, Ziegler TR, Nanes MS, Abrams SA, Tangpricha V. Vitamin D-mediated calcium absorption in patients with clinically stable Crohn's disease: a pilot study. Mol Nutr Food Res. 2010 Aug;54(8):1085-91. doi: 10.1002/mnfr.200900351. PMID 20306476