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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00427804 |
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Date of registration:
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25/01/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Tumor Necrosis Factor Decreases Vitamin D Dependant Calcium Absorption
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Scientific title:
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Tumor Necrosis Factor-a Induces Vitamin D Resistance in Small Intestinal Calcium Absorption |
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Date of first enrolment:
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January 2007 |
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Target sample size:
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9 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00427804 |
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Study type:
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Interventional |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Vin Tangpricha, M.D. Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Emory University |
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Crohn's Disease
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Intervention(s)
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Drug: calcitriol
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Primary Outcome(s)
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Fractional Absorption of Calcium
[Time Frame: 7 week]
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Intestinal Absorption of Calcium
[Time Frame: 12 Weeks]
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Secondary ID(s)
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Vitamin D-2007
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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