We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Diet Intervention in Food Sensitive Patients With IgA Nephropathy (DIIGA)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by Uppsala University Hospital.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01203007
First Posted: September 16, 2010
Last Update Posted: September 17, 2010
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.
Collaborators:
University Hospital, Linkoeping
Haukeland University Hospital
Smerud Medical Research International AS
Information provided by:
Uppsala University Hospital
  Purpose
The purpose of this study is to assess whether a tailored diet, eliminating antigens to which IgA nephropathy patients have demonstrated sensitivity, will have an effect on proteinuria, renal function and other immunological variables.

Condition Intervention
IGA Nephropathy Dietary Supplement: Tailored diet Dietary Supplement: Low antigen content diet

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of 6 Months Diet Intervention in Food Sensitive Patients With IgA Nephropathy

Resource links provided by NLM:


Further study details as provided by Uppsala University Hospital:

Primary Outcome Measures:
  • Proteinuria [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Renal function [ Time Frame: 6 months ]
    Glomerular filtration rate (GFR)

  • IgA/IgG immune complexes, incl. glycosylation [ Time Frame: 6 months ]
  • IgA/IgG to dietary antigens [ Time Frame: 6 months ]
  • Hematuria [ Time Frame: 6 months ]

Estimated Enrollment: 40
Study Start Date: September 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tailored diet
Tailored diet according to demonstrated food sensitivity
Dietary Supplement: Tailored diet
Tailored diet according to demonstrated food sensitivity, 6 months
Experimental: Low-antigen content (LAC) diet
Low-antigen content diet
Dietary Supplement: Low antigen content diet
Low-antigen content diet for one month

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Above 18 years
  • IgA nephropathy (IgAN), verified by biopsy
  • Proteinuria > 1 g/24 h
  • Having signed informed consent form

Exclusion Criteria:

  • Participation in another clinical trial
  • Patients with celiac disease
  • Introduction of an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blockers (ARB) during the last three months prior to inclusion
  • Patients treated with immunosuppressive or systemic corticosteroid drugs within the last twelve months
  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): NCT01203007


Contacts
Contact: Bengt Fellström, MD, PhD +46 18 611 4348 bengt.fellstrom@medsci.uu.se
Contact: Hilde K Smerud, MScPharm +47 9011 6812 hilde.smerud@medsci.uu.se

Locations
Norway
Haukeland University Hospital Not yet recruiting
Bergen, Norway
Principal Investigator: Rune Bjørneklett, MD         
Sweden
Linköping University Hospital Not yet recruiting
Linköping, Sweden
Principal Investigator: Anders Fernström, MD, PhD         
Uppsala University Hospital Not yet recruiting
Uppsala, Sweden
Contact: Bengt Fellström, MD, PhD    +46 18 611 4348    bengt.fellstrom@medsci.uu.se   
Contact: Hilde K Smerud, MScPharm    +479011 6812    hilde.smerud@medsci.uu.se   
Principal Investigator: Bengt Fellström, MD, PhD         
Sponsors and Collaborators
Uppsala University Hospital
University Hospital, Linkoeping
Haukeland University Hospital
Smerud Medical Research International AS
Investigators
Study Director: Hilde K Smerud, MScPharm Uppsala University Hospital
  More Information

Responsible Party: Bengt Fellström, Uppsala University Hospital
ClinicalTrials.gov Identifier: NCT01203007     History of Changes
Other Study ID Numbers: SMR-2259
First Submitted: September 15, 2010
First Posted: September 16, 2010
Last Update Posted: September 17, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases