Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Addition of Short Course of Prednisolone to Gluten Free Diet in Naive Celiac Disease Patients (CD)

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.
 
ClinicalTrials.gov Identifier: NCT01045837
Recruitment Status : Completed
First Posted : January 11, 2010
Last Update Posted : January 19, 2012
Sponsor:
Information provided by (Responsible Party):
Govind K Makharia, All India Institute of Medical Sciences, New Delhi

Tracking Information
First Submitted Date  ICMJE January 8, 2010
First Posted Date  ICMJE January 11, 2010
Last Update Posted Date January 19, 2012
Study Start Date  ICMJE April 2009
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2010)
  • Proportion of patients having improvement in symptoms at 4 weeks [ Time Frame: 4 weeks ]
  • Proportion of patients having improvement in histological improvement by at least one grade at 4 weeks [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2010)
Proportion of patients showing normalization of histological abnormalities at 6 months [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Addition of Short Course of Prednisolone to Gluten Free Diet in Naive Celiac Disease Patients
Official Title  ICMJE Effect of Addition of Short Course of Prednisolone to Gluten Free Diet and Gluten Free Diet Alone in the Recovery of Clinical, Histological and Immunological Features in Naive Adult Patients With Celiac Disease
Brief Summary

Withdrawal of gluten, the culprit antigen, is the definite treatment for celiac disease. Weeks to months after gluten withdrawal from the diet before the clinical manifestations, histological features start improving. Many of the adult patients are in the critical phase where even weeks may matter especially those in their adolescence where height growth has limited potential.

Suppression of immune system using a short course of steroid might retard the immune mediated destruction of the villi while the effect of gluten withdrawal sets in. Steroids are known to be effective in the management of refractory celiac disease. Therefore, the investigators hypothesized that addition of a short course of steroid to gluten free diet may enhance intestinal mucosal recovery and thus clinical manifestations

Detailed Description Celiac disease is a chronic systemic autoimmune disorder induced by gluten proteins present in wheat, barley, and rye. Steroids affect proliferative responses of both B and T cells in vitro, and the production of lymphokines (migratory inhibitory factor) by cultured cells. Steroids inhibit the effect of gluten proteins through their action on elements of the immune system. Glucocorticoids are reserved for severely ill patients, who present with celiac crisis, gliadin shock, and refractory sprue. We hypothesized that addition of a short course of steroid to gluten free diet may enhance intestinal mucosal recovery and thus clinical manifestations.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Celiac Disease
Intervention  ICMJE
  • Drug: Prednisolone and Gluten free diet
    Gluten free diet and Oral Prednisolone in a dose of 1 mg/ kg will be given for a period of 4 weeks, thereafter Gluten free diet alone will be continued
    Other Names:
    • Steroids
    • Wysolone
  • Behavioral: Gluten free diet
    Only gluten free diet will be given in this group
    Other Name: Gluten
Study Arms  ICMJE
  • Active Comparator: Prednisolone and Gluten free diet
    Gluten free diet and prednisolone in the dose of 1 mg/kg/d over a period of 4 weeks.
    Intervention: Drug: Prednisolone and Gluten free diet
  • Placebo Comparator: Gluten free diet
    Gluten free alone will be given in this group
    Intervention: Behavioral: Gluten free diet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 18, 2012)
33
Original Estimated Enrollment  ICMJE
 (submitted: January 8, 2010)
40
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Naïve patients with celiac disease (CD will be diagnosed as per revised European Society of Pediatric Gastroenterology and Nutrition criteria
  • Both sexes
  • Age>12 years

Exclusion Criteria:

  • Partially treated celiac disease
  • Co-existent systemic diseases
  • HIV seropositive
  • Seropositive with HBsAg , Anti HCV Ab
  • Past H/O tuberculosis
  • Evidence of active tuberculosis
  • Unwilling patient
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01045837
Other Study ID Numbers  ICMJE Celiac-Prednisolone
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Govind K Makharia, All India Institute of Medical Sciences, New Delhi
Study Sponsor  ICMJE All India Institute of Medical Sciences, New Delhi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Govind Makharia, MD, DM All India Institue of Medical Sciences
PRS Account All India Institute of Medical Sciences, New Delhi
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP