NCT00427804

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Jan 2007

Typical duration for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2007

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

September 2, 2011

Completed
Last Updated

February 4, 2013

Status Verified

January 1, 2013

Enrollment Period

2.6 years

First QC Date

January 25, 2007

Results QC Date

August 3, 2011

Last Update Submit

January 30, 2013

Conditions

Rheumatoid ArthritisCrohn's Disease

Keywords

Calcium absorptionVitamin D

Outcome Measures

Primary Outcomes (2)

  • Intestinal Absorption of Calcium

    12 Weeks

  • Fractional Absorption of Calcium

    Fractional absorption of calcium (see citation for complete details)

    7 week

Study Arms (1)

Calcitriol

EXPERIMENTAL

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

Interventions

calcitriolDRUG

0.25 mcg PO BID for 1 week for low dose then 0.25 mcg PO BID for high dose

Calcitriol

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males
  • Age 18 to 50
  • History of Crohn's disease or Rheumatoid Arthritis (cases) or healthy individuals (controls)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlanta VAMC

Atlanta, Georgia, 30030, United States

Location

Related Publications (1)

  • Kumari 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: 20306476RESULT

MeSH Terms

Conditions

Arthritis, RheumatoidCrohn Disease

Interventions

Calcitriol

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesInflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

DihydroxycholecalciferolsHydroxycholecalciferolsCholecalciferolCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Results Point of Contact

Title
Vin Tangpricha, M.D., Ph.D.
Organization
Emory University
vin.tangpricha@emory.edu
404-727-7254

Study Officials

  • Vin Tangpricha, M.D. Ph.D.

    Emory University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician

Study Record Dates

First Submitted

January 25, 2007

First Posted

January 29, 2007

Study Start

January 1, 2007

Primary Completion

August 1, 2009

Study Completion

November 1, 2009

Last Updated

February 4, 2013

Results First Posted

September 2, 2011

Record last verified: 2013-01

Locations

US(1)