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Tumor Necrosis Factor Decreases Vitamin D Dependant Calcium Absorption

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00427804
First Posted: January 29, 2007
Last Update Posted: February 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Emory University
Information provided by (Responsible Party):
Vin Tangpricha, Atlanta VA Medical Center
  Purpose
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.

Condition Intervention
Rheumatoid Arthritis Crohn's Disease Drug: calcitriol

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tumor Necrosis Factor-α Induces Vitamin D Resistance in Small Intestinal Calcium Absorption

Resource links provided by NLM:


Further study details as provided by Vin Tangpricha, Atlanta VA Medical Center:

Primary Outcome Measures:
  • Intestinal Absorption of Calcium [ Time Frame: 12 Weeks ]
  • Fractional Absorption of Calcium [ Time Frame: 7 week ]
    Fractional absorption of calcium (see citation for complete details)


Enrollment: 9
Study Start Date: January 2007
Study Completion Date: November 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Calcitriol
Calcitriol 0.25 mcg orally twice a day for 7 days or calcitriol 0.50 mcg orally twice a day for 7 days.
Drug: calcitriol
0.25 mcg PO BID for 1 week for low dose then 0.25 mcg PO BID for high dose

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00427804


Locations
United States, Georgia
Atlanta VAMC
Atlanta, Georgia, United States, 30030
Sponsors and Collaborators
Atlanta VA Medical Center
Emory University
Investigators
Principal Investigator: Vin Tangpricha, M.D. Ph.D. Emory University
  More Information

Publications:
Responsible Party: Vin Tangpricha, Staff Physician, Atlanta VA Medical Center
ClinicalTrials.gov Identifier: NCT00427804     History of Changes
Other Study ID Numbers: Vitamin D-2007
First Submitted: January 25, 2007
First Posted: January 29, 2007
Results First Submitted: August 3, 2011
Results First Posted: September 2, 2011
Last Update Posted: February 4, 2013
Last Verified: January 2013

Keywords provided by Vin Tangpricha, Atlanta VA Medical Center:
Calcium absorption
Vitamin D

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Crohn Disease
Necrosis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathologic Processes
Vitamins
Vitamin D
Ergocalciferols
Calcitriol
Calcium, Dietary
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents


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