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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Uppsala University Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
University Hospital, Linkoeping
Haukeland University Hospital
Smerud Medical Research International AS
Information provided by:
Uppsala University Hospital
ClinicalTrials.gov Identifier:
NCT01203007
First received: September 15, 2010
Last updated: September 16, 2010
Last verified: September 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of 6 Months Diet Intervention in Food Sensitive Patients With IgA Nephropathy

Further study details as provided by Uppsala University Hospital:

Primary Outcome Measures:
  • Proteinuria [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Renal function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Glomerular filtration rate (GFR)

  • IgA/IgG immune complexes, incl. glycosylation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • IgA/IgG to dietary antigens [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Hematuria [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Bengt Fellström, Uppsala University Hospital
ClinicalTrials.gov Identifier: NCT01203007     History of Changes
Other Study ID Numbers: SMR-2259
Study First Received: September 15, 2010
Last Updated: September 16, 2010
Health Authority: Sweden: Regionala etikprövningsnämnden i Uppsala
Norway: Regional etisk komite, Vest

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

ClinicalTrials.gov processed this record on May 23, 2013